Agency classClass IIOur severity:High FDA (Devices)·Z-0839-2020·Announced 2020-01-29

Soredex DIGORA Optime X-Ray Imager PSU Insulation Recall

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (electrical short circuit, heating, smoke) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.

Plain-English summary

Palodex Group Oy is recalling 297 units of the Soredex DIGORA Optime Solid State X-Ray Imager (Flat Panel/Digital Imager). The recall covers specific serial numbers and power supply units (PSUs) with nine-digit serial numbers beginning with 1143, 1221, 1224, or 1229. The affected devices were distributed in Wisconsin and Pennsylvania in the United States, as well as in numerous countries internationally.

The recall is due to slow degradation of the plastic insulation used in the PSU DC plug. This degradation may result in short circuiting, which can cause heating and melting. The melting may generate smoke and eventually cause the power supply to fail. The source text does not report any injuries, illnesses, or deaths associated with this defect.

Healthcare facilities and users should identify affected units by checking the serial numbers against the provided list. Users should contact Palodex Group Oy for instructions on how to address the defect. The source text does not specify a particular corrective action such as repair or replacement, nor does it provide a specific date for the recall initiation.

The recalled product

Product: Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
Manufacturer: Palodex Group Oy
Category: Medical Device — Dental Imaging
Hazard: fire
burn-injury
smoke
Affected units: 297

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Serial Number: SJ1208232
SJ1208233
SJ1208234
SJ1208235
SJ1208236
SJ1208238
SJ1208248
SJ1208249
SJ1208251
SJ1208252
SJ1208253
SJ1208254
SJ1208255
SJ1208256
SJ1208257
SJ1208268
SJ1208269
SJ1208270
SJ1208296
SJ1208297

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 4 recalled by Palodex Group Oy under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · Palodex Group Oy

See all →

High
Dental X-Ray Device Testing Defect May Affect Image Repeatability
FDA (Devices) · 2024-08-21
High
Gendex X-Ray Imager Recall Due to Power Supply Insulation Degradation
FDA (Devices) · 2020-01-29
Severe
Palodex Dental X-Ray Imagers Recalled for Power Supply Fire Risk
FDA (Devices) · 2020-01-29
Severe
KaVo Scan eXam X-Ray Imager Recalled for Power Supply Fire Risk
FDA (Devices) · 2020-01-29

Same hazard · fire