FDA (Devices) recall action 84544
The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Palodex Group Oy is recalling 297 Soredex DIGORA Optime X-ray imagers because plastic insulation in the power supply may degrade, causing short circuits, heating, and smoke.
Palodex Group Oy is recalling Gendex GXPS-500 X-ray imagers because plastic insulation in the power supply may degrade, causing short circuits, heating, and smoke.
Palodex Group Oy is recalling Instrumentarium Dental Express X-ray imagers because slow degradation of plastic insulation in the power supply unit may cause short circuits, heating, and smoke.
Palodex Group Oy is recalling KaVo Scan eXam X-ray imagers because plastic insulation degradation in the power supply may cause short circuits, heating, and smoke.