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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98977

8 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 07, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

8 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 8

Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

Z-2284-2026
Recall number
Z-2284-2026
Initiated
December 07, 2023
Classification
Class II
Status
Ongoing
Quantity
16 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

Code information

UDI (01)00884838099203(21)3, (01)00884838099203(21)7, (01)00884838085275(21)131, (01)00884838099203(21)54, (01)00884838085275(21)84, (01)00884838099203(21)6, (01)00884838099203(21)93, (01)00884838085275(21)132, (01)00884838099203(21)69, (01)00884838099203(21)9, (01)00884838099203(21)115, (01)00884838099203(21)85, (01)00884838099203(21)19, (01)00884838099203(21)49, (01)00884838099203(21)108, (01)00884838085275(21)108.

Distribution pattern

US Nationwide distribution.

device · product 2 of 8

Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

Z-2285-2026
Recall number
Z-2285-2026
Initiated
December 07, 2023
Classification
Class II
Status
Ongoing
Quantity
27 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

Code information

UDI (01)00884838085282(21)209, (01)00884838099210(21)100, (01)00884838099210(21)254, (01)00884838099210(21)256, (01)00884838099210(21)257, (01)00884838099210(21)265, (01)00884838099210(21)255, (01)00884838099210(21)99, (01)00884838085282(21)260, (01)00884838085282(21)261, (01)00884838099210(21)69, (01)00884838099210(21)12, (01)00884838085282(21)314, (01)00884838085282(21)259, (01)00884838099210(21)15, (01)00884838099210(21)19, (01)00884838099210(21)23, (01)00884838099210(21)17, (01)00884838085282(21)258, (01)00884838099210(21)55, (01)00884838099210(21)45, (01)00884838085282(21)270, (01)00884838099210(21)187, (01)00884838099210(21)223, (01)00884838099210(21)44, (01)00884838099210(21)113, (01)00884838099210(21)112.

Distribution pattern

US Nationwide distribution.

device · product 3 of 8

Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

Z-2286-2026
Recall number
Z-2286-2026
Initiated
December 07, 2023
Classification
Class II
Status
Ongoing
Quantity
3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

Code information

UDI (01)00884838099227(21)88, (01)00884838099227(21)135, (01)00884838099227(21)63.

Distribution pattern

US Nationwide distribution.

device · product 4 of 8

Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

Z-2287-2026
Recall number
Z-2287-2026
Initiated
December 07, 2023
Classification
Class II
Status
Ongoing
Quantity
51 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

Code information

UDI (01)00884838099234(21)67, (01)00884838099234(21)49, (01)00884838099234(21)10, (01)00884838099234(21)36, (01)00884838099234(21)64, (01)00884838099234(21)110, (01)00884838099234(21)328, (01)00884838099234(21)149, (01)00884838099234(21)213, (01)00884838099234(21)45, (01)00884838099234(21)159, (01)00884838099234(21)18, (01)00884838099234(21)231, (01)00884838099234(21)61, (01)00884838099234(21)204, (01)00884838099234(21)273, (01)00884838099234(21)76, (01)00884838099234(21)150, (01)00884838099234(21)132, (01)00884838099234(21)189, (01)00884838099234(21)17, (01)00884838099234(21)47, (01)00884838099234(21)38, (01)00884838099234(21)87, (01)00884838099234(21)128, (01)00884838099234(21)32, (01)00884838099234(21)23, (01)00884838099234(21)25, (01)00884838099234(21)62, (01)00884838099234(21)181, (01)00884838099234(21)177, (01)00884838099234(21)48, (01)00884838099234(21)153, (01)00884838099234(21)79, (01)00884838099234(21)80, (01)00884838099234(21)157, (01)00884838099234(21)24, (01)00884838099234(21)187, (01)00884838099234(21)26, (01)00884838099234(21)29, (01)00884838099234(21)122, (01)00884838099234(21)127, (01)00884838099234(21)6, (01)00884838099234(21)123, (01)00884838099234(21)124, (01)00884838099234(21)92, (01)00884838099234(21)215, (01)00884838099234(21)91, (01)00884838099234(21)205, (01)00884838099234(21)20, (01)00884838099234(21)37a.

Distribution pattern

US Nationwide distribution.

device · product 5 of 8

Philips Azurion 7B12/12, Model Numbers: 722067, 722225 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

Z-2288-2026
Recall number
Z-2288-2026
Initiated
December 07, 2023
Classification
Class II
Status
Ongoing
Quantity
51 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

Code information

UDI (01)00884838099265(21)104, (01)00884838085350(21)221, (01)00884838099265(21)153, (01)00884838099265(21)46, (01)00884838099265(21)28, (01)00884838085350(21)250, (01)00884838099265(21)72, (01)00884838099265(21)208, (01)00884838099265(21)41, (01)00884838099265(21)122, (01)00884838099265(21)147, (01)00884838085350(21)225, (01)00884838099265(21)262, (01)00884838099265(21)112, (01)00884838099265(21)110, (01)00884838099265(21)207, (01)00884838099265(21)68, (01)00884838099265(21)177, (01)00884838099265(21)29, (01)00884838099265(21)71, (01)00884838099265(21)37, (01)00884838099265(21)175, (01)00884838099265(21)148, (01)00884838099265(21)205, , (01)00884838099265(21)229, (01)00884838099265(21)228, (01)00884838085350(21)277, (01)00884838085350(21)115, (01)00884838099265(21)157, (01)00884838085350(21)163, (01)00884838099265(21)268, (01)00884838085350(21)75, (01)00884838085350(21)132, (01)00884838085350(21)147, (01)00884838085350(21)208, (01)00884838085350(21)104, (01)00884838085350(21)244, (01)00884838085350(21)234, (01)00884838099265(21)53, (01)00884838099265(21)259, (01)00884838099265(21)55, (01)00884838099265(21)235, (01)00884838099265(21)298, (01)00884838085350(21)70, (01)00884838099265(21)233, (01)00884838099265(21)141, (01)00884838099265(21)289, (01)00884838099265(21)249, (01)00884838099265(21)84, (01)00884838099265(21)111, (01)00884838099265(21)227.

Distribution pattern

US Nationwide distribution.

device · product 6 of 8

Philips Azurion 7B20/15, Model Numbers: 722068, 722226 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

Z-2289-2026
Recall number
Z-2289-2026
Initiated
December 07, 2023
Classification
Class II
Status
Ongoing
Quantity
156 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

Code information

UDI (01)00884838085367(21)547, (01)00884838099272(21)120, (01)00884838099272(21)122, (01)00884838099272(21)123, (01)00884838099272(21)124, (01)00884838099272(21)125, (01)00884838099272(21)126, (01)00884838099272(21)127, (01)00884838099272(21)153, (01)00884838099272(21)67, (01)00884838099272(21)209, (01)00884838099272(21)271, (01)00884838099272(21)675, (01)00884838099272(21)112, (01)00884838085367(21)467, (01)00884838085367(21)335, (01)00884838099272(21)113, (01)00884838099272(21)121, (01)00884838099272(21)139, (01)00884838099272(21)158, (01)00884838085367(21)455, (01)00884838085367(21)494, (01)00884838099272(21)239, (01)00884838099272(21)105, (01)00884838099272(21)678, (01)00884838099272(21)362, (01)00884838099272(21)114, (01)00884838085367(21)564, (01)00884838099272(21)403, (01)00884838085367(21)418, (01)00884838085367(21)440, (01)00884838099272(21)108, (01)00884838099272(21)545, (01)00884838099272(21)197, (01)00884838099272(21)380, (01)00884838099272(21)281, (01)00884838099272(21)495, (01)00884838099272(21)319, (01)00884838099272(21)339, (01)00884838099272(21)182, (01)00884838099272(21)183, (01)00884838085367(21)64, (01)00884838099272(21)325, (01)00884838099272(21)100, (01)00884838099272(21)272, (01)00884838099272(21)680, (01)00884838085367(21)42, (01)00884838099272(21)255, (01)00884838099272(21)341, (01)00884838099272(21)687, (01)00884838099272(21)350, (01)00884838099272(21)280, (01)00884838085367(21)323, (01)00884838099272(21)270, (01)00884838099272(21)254, (01)00884838099272(21)107, (01)00884838099272(21)144, (01)00884838085367(21)109, (01)00884838099272(21)294, (01)00884838099272(21)559, (01)00884838099272(21)98, (01)00884838099272(21)343, (01)00884838085367(21)443, (01)00884838099272(21)301, (01)00884838099272(21)117, (01)00884838085367(21)322, (01)00884838085367(21)373, (01)00884838085367(21)442, (01)00884838099272(21)244, (01)00884838099272(21)332, (01)00884838085367(21)308, (01)00884838099272(21)78, (01)00884838099272(21)374, (01)00884838099272(21)11, (01)00884838085367(21)354, (01)00884838099272(21)441, (01)00884838099272(21)129, (01)00884838099272(21)180, (01)00884838085367(21)279, (01)00884838099272(21)442, (01)00884838085367(21)400, (01)00884838099272(21)220, (01)00884838099272(21)189, (01)00884838099272(21)190, (01)00884838099272(21)446, (01)00884838085367(21)510, (01)00884838085367(21)111, (01)00884838085367(21)113, (01)00884838085367(21)446, (01)00884838099272(21)208, (01)00884838099272(21)554, (01)00884838085367(21)330, (01)00884838085367(21)288, (01)00884838099272(21)360, (01)00884838099272(21)337, (01)00884838099272(21)159, (01)00884838099272(21)326, (01)00884838099272(21)400, (01)00884838085367(21)329, (01)00884838099272(21)175, (01)00884838099272(21)427, (01)00884838099272(21)464, (01)00884838099272(21)468, (01)00884838085367(21)472, (01)00884838085367(21)470, (01)00884838085367(21)457, (01)00884838085367(21)520, (01)00884838085367(21)490, (01)00884838099272(21)143, (01)00884838099272(21)262, (01)00884838085367(21)103, (01)00884838099272(21)391, (01)00884838085367(21)150, (01)00884838085367(21)277, (01)00884838099272(21)173, (01)00884838085367(21)172, (01)00884838099272(21)147, (01)00884838099272(21)204, (01)00884838099272(21)467, (01)00884838085367(21)356, (01)00884838085367(21)130, (01)00884838099272(21)260, (01)00884838099272(21)381, (01)00884838099272(21)508, (01)00884838099272(21)419, (01)00884838099272(21)313, (01)00884838085367(21)469, (01)00884838099272(21)472, (01)00884838099272(21)318, (01)00884838099272(21)473, (01)00884838085367(21)431, (01)00884838099272(21)174, (01)00884838099272(21)383, (01)00884838099272(21)181, (01)00884838099272(21)463, (01)00884838099272(21)205, (01)00884838099272(21)59, (01)00884838099272(21)361, (01)00884838085367(21)114, (01)00884838099272(21)555, (01)00884838099272(21)379, (01)00884838085367(21)511, (01)00884838085367(21)477, (01)00884838099272(21)266, (01)00884838099272(21)398, (01)00884838099272(21)593, (01)00884838099272(21)75, (01)00884838099272(21)19, (01)00884838085367(21)413, (01)00884838085367(21)337, (01)00884838099272(21)215, (01)00884838099272(21)213, (01)00884838099272(21)214, (01)00884838099272(21)469, (01)00884838099272(21)219, (01)00884838099272(21)462.

Distribution pattern

US Nationwide distribution.

device · product 7 of 8

Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

Z-2290-2026
Recall number
Z-2290-2026
Initiated
December 07, 2023
Classification
Class II
Status
Ongoing
Quantity
167 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

Code information

UDI (01)00884838099241(21)85, (01)00884838099241(21)312, (01)00884838099241(21)332, (01)00884838099241(21)533, (01)00884838099241(21)479, (01)00884838099241(21)189, (01)00884838099241(21)47, (01)00884838085251(21)840, (01)00884838099241(21)352, (01)00884838099241(21)681, (01)00884838099241(21)391, (01)00884838099241(21)328, (01)00884838085251(21)870, (01)00884838099241(21)388, (01)00884838099241(21)581, (01)00884838099241(21)570, (01)00884838099241(21)77, (01)00884838099241(21)448, (01)00884838099241(21)571, (01)00884838099241(21)495, (01)00884838085251(21)679, (01)00884838099241(21)439, (01)00884838099241(21)628, (01)00884838099241(21)36, (01)00884838099241(21)580, (01)00884838099241(21)799, (01)00884838099241(21)577, (01)00884838085251(21)513, (01)00884838085251(21)833, (01)00884838085251(21)566, (01)00884838099241(21)323, (01)00884838099241(21)252, (01)00884838099241(21)626, (01)00884838099241(21)261, (01)00884838099241(21)125, (01)00884838099241(21)207, (01)00884838099241(21)329, (01)00884838099241(21)560, (01)00884838099241(21)561, (01)00884838099241(21)205, (01)00884838099241(21)379, (01)00884838099241(21)440, (01)00884838099241(21)204, (01)00884838099241(21)192, (01)00884838099241(21)197, (01)00884838085251(21)921, (01)00884838099241(21)177, (01)00884838085251(21)700, (01)00884838099241(21)37, (01)00884838099241(21)340, (01)00884838099241(21)357, (01)00884838099241(21)282, (01)00884838099241(21)214, (01)00884838085251(21)1007, (01)00884838099241(21)44, (01)00884838085251(21)862, (01)00884838099241(21)210, (01)00884838099241(21)336, (01)00884838099241(21)206, (01)00884838099241(21)343, (01)00884838085251(21)786, (01)00884838099241(21)365, (01)00884838099241(21)390, (01)00884838099241(21)186, (01)00884838099241(21)187, (01)00884838099241(21)631, (01)00884838099241(21)87, (01)00884838099241(21)373, (01)00884838099241(21)514, (01)00884838099241(21)69, (01)00884838099241(21)256, (01)00884838099241(21)679, (01)00884838099241(21)29, (01)00884838099241(21)67, (01)00884838099241(21)503, (01)00884838099241(21)432, (01)00884838099241(21)131, (01)00884838099241(21)704, (01)00884838099241(21)301, (01)00884838099241(21)456, (01)00884838085251(21)803, (01)00884838099241(21)659, (01)00884838099241(21)242, (01)00884838099241(21)746, (01)00884838099241(21)171, (01)00884838099241(21)457, (01)00884838099241(21)455, (01)00884838099241(21)221, (01)00884838099241(21)454, (01)00884838099241(21)318, (01)00884838099241(21)229, (01)00884838099241(21)230, (01)00884838099241(21)262, (01)00884838085251(21)890, (01)00884838085251(21)626, (01)00884838085251(21)697, (01)00884838099241(21)308, (01)00884838099241(21)124, (01)00884838099241(21)198, (01)00884838099241(21)433, (01)00884838085251(21)684, (01)00884838099241(21)566, (01)00884838099241(21)126, (01)00884838085251(21)829, (01)00884838099241(21)880, (01)00884838085251(21)143, (01)00884838099241(21)665, (01)00884838099241(21)188, (01)00884838085251(21)824, (01)00884838085251(21)649, (01)00884838099241(21)367, (01)00884838099241(21)52, (01)00884838099241(21)371, (01)00884838099241(21)127, (01)00884838099241(21)105, (01)00884838099241(21)572, (01)00884838099241(21)104, (01)00884838099241(21)334, (01)00884838099241(21)627, (01)00884838099241(21)458, (01)00884838099241(21)487, (01)00884838099241(21)463, (01)00884838099241(21)470, (01)00884838085251(21)902, (01)00884838099241(21)96, (01)00884838099241(21)277, (01)00884838099241(21)211, (01)00884838085251(21)317, (01)00884838085251(21)709, (01)00884838099241(21)97, (01)00884838099241(21)161, (01)00884838099241(21)386, (01)00884838099241(21)208, (01)00884838099241(21)361, (01)00884838099241(21)258, (01)00884838099241(21)597, (01)00884838085251(21)725, (01)00884838085251(21)728, (01)00884838099241(21)180, (01)00884838085251(21)441, (01)00884838099241(21)668, (01)00884838099241(21)377, (01)00884838099241(21)882, (01)00884838085251(21)906, (01)00884838099241(21)565, (01)00884838099241(21)223, (01)00884838099241(21)196, (01)00884838099241(21)130, (01)00884838099241(21)453, (01)00884838099241(21)452, (01)00884838099241(21)269, (01)00884838085251(21)788, (01)00884838099241(21)567, (01)00884838099241(21)449, (01)00884838085251(21)141, (01)00884838085251(21)279, (01)00884838085251(21)644, (01)00884838099241(21)435, (01)00884838099241(21)441, (01)00884838085251(21)844, (01)00884838085251(21)876, (01)00884838085251(21)748, (01)00884838099241(21)669, (01)00884838099241(21)351, (01)00884838099241(21)508, (01)00884838099241(21)750, (01)00884838099241(21)164.

Distribution pattern

US Nationwide distribution.

device · product 8 of 8

Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

Z-2291-2026
Recall number
Z-2291-2026
Initiated
December 07, 2023
Classification
Class II
Status
Ongoing
Quantity
31 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

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Reason for recall

During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

Code information

UDI (01)00884838099258(21)450, (01)00884838099258(21)750, (01)00884838099258(21)409, (01)00884838099258(21)262, (01)00884838099258(21)275, (01)00884838099258(21)277, (01)00884838099258(21)295, (01)00884838099258(21)272, (01)00884838099258(21)261, (01)00884838099258(21)630, (01)00884838099258(21)1003, (01)00884838099258(21)1315, (01)00884838099258(21)381, (01)00884838099258(21)959, (01)00884838085268(21)1013, (01)00884838085268(21)1412, (01)00884838099258(21)232, (01)00884838085268(21)460, (01)00884838085268(21)1387, (01)00884838099258(21)260, (01)00884838099258(21)1019, (01)00884838099258(21)1371, (01)00884838085268(21)40, (01)00884838085268(21)43, (01)00884838085268(21)35, (01)00884838099258(21)1049, (01)00884838099258(21)1484, (01)00884838099258(21)1083, (01)00884838085268(21)703307, (01)00884838099258(21)246, (01)00884838099258(21)475.

Distribution pattern

US Nationwide distribution.

Field note

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