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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84544

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

Open FDA event record

Event summary

Timeline bucket
January 07, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Palodex Group Oy

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

4 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 4

Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

Z-0839-2020
Recall number
Z-0839-2020
Initiated
January 07, 2020
Classification
Class II
Status
Terminated
Recalling firm
Palodex Group Oy
Quantity
297

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express, GXPS-500 systems may result in short circuiting which may cause heating and melting. The melting may generate smoke and eventually cause the PSU to fail.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express, GXPS-500 systems may result in short circuiting which may cause heating and melting. The melting may generate smoke and eventually cause the PSU to fail.

Code information

Serial Number: SJ1208232, SJ1208233, SJ1208234, SJ1208235, SJ1208236, SJ1208238, SJ1208248, SJ1208249, SJ1208251, SJ1208252, SJ1208253, SJ1208254, SJ1208255, SJ1208256, SJ1208257, SJ1208268, SJ1208269, SJ1208270, SJ1208296, SJ1208297, SJ1208298, SJ1208299, SJ1208300, SJ1208301, SJ1208303, SJ1208304, SJ1208305, SJ1208306, SJ1208307, SJ1208309, SJ1208409, SJ1208415, SJ1208416, SJ1208417, SJ1208418, SJ1208421, SJ1208431, SJ1208433, SJ1208434, SJ1208436, SJ1208437, SJ1208439, SJ1208440, SJ1208441, SJ1208442, SJ1208446, SJ1208447, SJ1208449, SJ1208451, SJ1208452, SJ1208453, SJ1208454, SJ1208455, SJ1208456, SJ1208457, SJ1208460, SJ1208461, SJ1208462, SJ1208465, SJ1208519, SJ1208523, SJ1208524, SJ1208533, SJ1208534, SJ1208535, SJ1208536, SJ1208537, SJ1208538, SJ1208556, SJ1208558, SJ1208559, SJ1208560, SJ1208561, SJ1208563, SJ1208571, SJ1208572, SJ1208573, SJ1208574, SJ1208575, SJ1208577, SJ1208578, SJ1208579, SJ1208580, SJ1208581, SJ1208583, SJ1208584, SJ1208585, SJ1208586, SJ1208588, SJ1208596, SJ1208597, SJ1208598, SJ1208599, SJ1208600, SJ1208601, SJ1208602, SJ1208603, SJ1208604, SJ1208605, SJ1208606, SJ1208607, SJ1208608, SJ1208609, SJ1208610, SJ1210176, SJ1210177, SJ1210178, SJ1210179, SJ1210180, SJ1210181, SJ1210184, SJ1210185, SJ1210187, SJ1210188, SJ1210189, SJ1210191, SJ1210192, SJ1210193, SJ1210194, SJ1210195, SJ1210197, SJ1210200, SJ1210201, SJ1210202, SJ1210204, SJ1210205, SJ1210206, SJ1210208, SJ1210209, SJ1210210, SJ1210213, SJ1210219, SJ1210281, SJ1210282, SJ1210283, SJ1210284, SJ1210285, SJ1210287, SJ1210288, SJ1210289, SJ1210291, SJ1210292, SJ1210293, SJ1210295, SJ1210297, SJ1210298, SJ1210300, SJ1210310, SJ1210312, SJ1210313, SJ1210314, SJ1210315, SJ1210316, SJ1210317, SJ1210318, SJ1210319, SJ1210320, SJ1210322, SJ1210323, SJ1210324, SJ1210326, SJ1210398, SJ1210400, SJ1210401, SJ1210402, SJ1210404, SJ1210416, SJ1210417, SJ1210497, SJ1210499, SJ1210500, SJ1210501, SJ1210502, SJ1210503, SJ1210504, SJ1210506, SJ1210508, SJ1210511, SJ1210512, SJ1210514, SJ1210515, SJ1210528, SJ1210529, SJ1210530, SJ1210534, SJ1210535, SJ1210536, SJ1210538, SJ1210540, SJ1210541, SJ1210542, SJ1211114, SJ1211117, SJ1211118, SJ1211121, SJ1211123, SJ1211127, SJ1211129, SJ1211130, SJ1211131, SJ1211132, SJ1211133, SJ1211134, SJ1211135, SJ1211137, SJ1211138, SJ1211224, SJ1211225, SJ1211226, SJ1211227, SJ1211228, SJ1211229, SJ1211230, SJ1211231, SJ1211232, SJ1211233, SJ1211234, SJ1211235, SJ1211236, SJ1211237, SJ1211238, SJ1211239, SJ1211240, SJ1211241, SJ1211242, SJ1211243, SJ1211244, SJ1211245, SJ1211246, SJ1211247, SJ1211248, SJ1211249, SJ1211250, SJ1211251, SJ1211252, SJ1211263, SJ1211341, SJ1211343, SJ1211345, SJ1211346, SJ1211347, SJ1211348, SJ1211349, SJ1211354, SJ1211355, SJ1211356, SJ1211358, SJ1211360, SJ1211378, SJ1211379, SJ1211382, SJ1311602, SJ1311603, SJ1311605, SJ1311606, SJ1311607, SJ1311608, SJ1311609, SJ1311610, SJ1311611, SJ1311612, SJ1311613, SJ1311614, SJ1311615, SJ1311616, SJ1311617, SJ1311766, SJ1311767, SJ1311768, SJ1311769, SJ1311770, SJ1311771, SJ1311772, SJ1311774, SJ1311776, SJ1311777, SJ1311778, SJ1311779, SJ1311780, SJ1311781, SJ1311783, SJ1312271, SJ1312481, SJ1313119, SJ1313121, SJ1313122, SJ1313124, SJ1313127, SJ1313220, SJ1313223, SJ1313224, SJ1313225, SJ1313228, SJ1313230, SJ1314362, SJ1314363, SJ1314368 PSU's having nine-digit serial numbers beginning with four digits as follows: 1143XXXXX 1221XXXXX 1224XXXXX and 1229XXXXX

Distribution pattern

US: WI and PA OUS: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COSTA RICA, CZECH REPUBLIC, DENMARK, ECUADOR, FINLAND, FRANCE, GERMANY, GREECE, HUNGARY, INDIA, ISRAEL, ITALY, JAPAN, KOREA, REPUBLIC OF, KUWAIT, MALAYSIA, MALTA, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PAKISTAN, POLAND, QATAR, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, REPUBLIC OF CHINA, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VIETNAM

device · product 2 of 4

Gendex GXPS-500 SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

Z-0840-2020
Recall number
Z-0840-2020
Initiated
January 07, 2020
Classification
Class II
Status
Terminated
Recalling firm
Palodex Group Oy
Quantity
101

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express, GXPS-500 systems may result in short circuiting which may cause heating and melting. The melting may generate smoke and eventually cause the PSU to fail.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express, GXPS-500 systems may result in short circuiting which may cause heating and melting. The melting may generate smoke and eventually cause the PSU to fail.

Code information

Serial Number: GJ1209488, GJ1209489, GJ1209491, GJ1209492, GJ1209493, GJ1209494, GJ1209495, GJ1209496, GJ1209498, GJ1209499, GJ1209504, GJ1209505, GJ1209506, GJ1209507, GJ1209509, GJ1209510, GJ1209511, GJ1209513, GJ1209514, GJ1209516, GJ1211287, GJ1211288, GJ1211289, GJ1211290, GJ1211291, GJ1211292, GJ1211293, GJ1211294, GJ1211295, GJ1211296, GJ1211297, GJ1211298, GJ1211299, GJ1211300, GJ1211301, GJ1211302, GJ1211303, GJ1211304, GJ1211305, GJ1211307, GJ1311619, GJ1311621, GJ1311622, GJ1311623, GJ1311624, GJ1311625, GJ1311626, GJ1311627, GJ1311628, GJ1311629, GJ1311630, GJ1311631, GJ1311632, GJ1311633, GJ1311634, GJ1311635, GJ1311636, GJ1311637, GJ1311638, GJ1311639, GJ1311640, GJ1311641, GJ1311642, GJ1311643, GJ1311644, GJ1311645, GJ1311646, GJ1311647, GJ1311648, GJ1311650, GJ1311651, GJ1311653, GJ1311656, GJ1311658, GJ1311659, GJ1311660, GJ1311661, GJ1311662, GJ1311663, GJ1311664, GJ1311665, GJ1311666, GJ1311669, GJ1311670, GJ1311671, GJ1311672, GJ1311673, GJ1311674, GJ1311675, GJ1311676, GJ1311677, GJ1311678, GJ1311679, GJ1311680, GJ1311681, GJ1311682, GJ1311683, GJ1311684, GJ1311685, GJ1311686, GJ1311722 PSU's having nine-digit serial numbers beginning with four digits as follows: 1143XXXXX 1221XXXXX 1224XXXXX and 1229XXXXX

Distribution pattern

US: WI and PA OUS: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COSTA RICA, CZECH REPUBLIC, DENMARK, ECUADOR, FINLAND, FRANCE, GERMANY, GREECE, HUNGARY, INDIA, ISRAEL, ITALY, JAPAN, KOREA, REPUBLIC OF, KUWAIT, MALAYSIA, MALTA, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PAKISTAN, POLAND, QATAR, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, REPUBLIC OF CHINA, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VIETNAM

device · product 3 of 4

KaVo Scan eXam SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

Z-0841-2020
Recall number
Z-0841-2020
Initiated
January 07, 2020
Classification
Class II
Status
Terminated
Recalling firm
Palodex Group Oy
Quantity
4,563 Total Globally (all products)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express, GXPS-500 systems may result in short circuiting which may cause heating and melting. The melting may generate smoke and eventually cause the PSU to fail.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express, GXPS-500 systems may result in short circuiting which may cause heating and melting. The melting may generate smoke and eventually cause the PSU to fail.

Code information

Serial Number: TBD (range from KJ1208178 to KJ1314403) PSU's having nine-digit serial numbers beginning with four digits as follows: 1143XXXXX 1221XXXXX 1224XXXXX and 1229XXXXX

Distribution pattern

US: WI and PA OUS: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COSTA RICA, CZECH REPUBLIC, DENMARK, ECUADOR, FINLAND, FRANCE, GERMANY, GREECE, HUNGARY, INDIA, ISRAEL, ITALY, JAPAN, KOREA, REPUBLIC OF, KUWAIT, MALAYSIA, MALTA, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PAKISTAN, POLAND, QATAR, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, REPUBLIC OF CHINA, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VIETNAM

device · product 4 of 4

Instrumentarium Dental Express SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

Z-0842-2020
Recall number
Z-0842-2020
Initiated
January 07, 2020
Classification
Class II
Status
Terminated
Recalling firm
Palodex Group Oy
Quantity
4,563 Total Globally (all products)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express, GXPS-500 systems may result in short circuiting which may cause heating and melting. The melting may generate smoke and eventually cause the PSU to fail.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express, GXPS-500 systems may result in short circuiting which may cause heating and melting. The melting may generate smoke and eventually cause the PSU to fail.

Code information

Serial Number: TBD (range from IJ1208217 to IJ1313309) PSU's having nine-digit serial numbers beginning with four digits as follows: 1143XXXXX 1221XXXXX 1224XXXXX and 1229XXXXX

Distribution pattern

US: WI and PA OUS: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COSTA RICA, CZECH REPUBLIC, DENMARK, ECUADOR, FINLAND, FRANCE, GERMANY, GREECE, HUNGARY, INDIA, ISRAEL, ITALY, JAPAN, KOREA, REPUBLIC OF, KUWAIT, MALAYSIA, MALTA, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PAKISTAN, POLAND, QATAR, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, REPUBLIC OF CHINA, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VIETNAM

Field note

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