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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87826

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
April 22, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Abbott Laboratories Inc. (St Jude Medical)

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

1 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 1

NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000

Z-1549-2021
Recall number
Z-1549-2021
Initiated
April 22, 2021
Classification
Class II
Status
Terminated
Quantity
318 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential capacitor failure which typically manifests as in inability to provide output on one or more channels. In some instances, users reported a charring/smoky odor or emission.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential capacitor failure which typically manifests as in inability to provide output on one or more channels. In some instances, users reported a charring/smoky odor or emission.

Code information

UDI 05415067022417: Serial Numbers: 18675078, 18709738, 18097502, 18023105, 18739462, 18650501, 18493702, 18718469, 18666645, 18634334, 18666647, 18427317, 18742999, 18709732, 18222185, 18222187, 18240730, 18201200, 18743003, 18343825, 18088294, 18201198, 18222190, 18240731, 17991994, 18132016, 18500164, 18522935, 18659497, 18750318, 18854584, 18718473, 18873320, 18240735, 18102325, 18648497, 18666643, 18666646, 18657521, 17991999, 18313159, 18614034, 18721060, 18493705, 18493709, 18610701, 18302046, 18192751, 18132012, 18222188, 18240728, 18718472, 18500167, 18132008, 18493711, 18313153, 17905956, 18060073, 18132011, 18102323, 18014268, 18014258, 18343824, 18240733, 18180086, 18675069, 18060017, 18060067, 18060071, 17964784, 18427318, 18648518, 18675068, 18648648, 18192752, 18709733, 18709734, 18302042, 18265068, 18659496, 18192753, 18192756, 18222183, 18522719, 18705743, 18522937, 18644839, 18873319, 18102324, 18088297, 18659489, 18706571, 18192754, 18622842, 18240729, 18180085, 18659495, 18187525, 18192750, 18115250, 18714394, 18666648, 18070518, 18072514, 18180082, 18634336, 18699641, 18854582, 18522709, 18704516, 18493701, 18716594, 18709741, 18873321, 18302048, 18644838, 18699645, 18102337, 18555754, 18743000, 18690921, 18180088, 18657520, 18522715, 18343821, 18201195, 18648650, 18522714, 18265071, 18709739, 18709735, 18023104, 18313165, 18070527, 18648652, 18650503, 18265072, 18666650, 18634337, 18313157, 18533473, 18648647, 18705742, 18644824, 18493707, 18699643, 18265070, 18343819, 17905963, 18070525, 18750319, 18343820, 18343823, 18650500, 17991997, 18701492, 18742994, 18014262, 18709742, 18854581, 18427321, 18659494, 18659493, 18644840, 18500166, 18533504, 18180083, 18427319, 18648008, 18648578, 18690926, 18657519, 18014259, 18014254, 18132092, 18302043, 18132014, 18003308, 18003311, 18003313, 18014255, 18014269, 18659490, 18047384, 18088295, 18014267, 18038591, 18023107, 18003310, 18014261, 18648619, 18648653, 18648655, 18102335, 18265069, 18854583, 18222191, 18014270, 18014271, 18690920, 18302047, 18696583, 18522716, 18427320, 18265066, 18302041, 18699642, 18192749, 18192755, 18675070, 18675076, 17860513, 17942355, 17959675, 17959676, 17959677, 17981234, 17981235, 18003314, 18003325, 18014272, 17860514, 17860515, 17905959, 17905962, 18187528, 18892887, 17905965, 17863602, 18302049, 18500165, 17856739, 18115251, 17856738, 17903459, 18115245, 18115246, 18126612, 18126613, 18500161, 17865145, 17856737, 18187529, 17981236, 17981233, 18132007, 18699646, 18180087, 18699640

Distribution pattern

US and AUSTRALIA, EGYPT, SOUTH AFRICA, BELGIUM, COLOMBIA, UNITED KINGDOM, COSTA RICA, ISRAEL, SOUTH KOREA, SINGAPORE, TAIWAN

Field note

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