Agency classClass IIOur severity:High FDA (Devices)·Z-0840-2020·Announced 2020-01-29

Gendex X-Ray Imager Recall Due to Power Supply Insulation Degradation

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.

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 (fire/smoke from electrical failure) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Palodex Group Oy is recalling 101 units of the Gendex GXPS-500 Solid State X-Ray Imager (Flat Panel/Digital Imager). The recall also covers the DIGORA Optime, Scan eXam, and Express systems. The affected units 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 power supply unit (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 PSU to fail.

Affected units can be identified by specific serial numbers listed in the agency documentation, including those beginning with GJ12, GJ13, or PSU serial numbers beginning with 1143, 1221, 1224, or 1229. Users should contact the recalling firm for further instructions on how to address the defect.

The recalled product

Product: Gendex GXPS-500 SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
Manufacturer: Palodex Group Oy
Category: Medical Device — Diagnostic Imaging
Hazard: fire
smoke
electrical-fault
Affected units: 101

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: GJ1209488
GJ1209489
GJ1209491
GJ1209492
GJ1209493
GJ1209494
GJ1209495
GJ1209496
GJ1209498
GJ1209499
GJ1209504
GJ1209505
GJ1209506
GJ1209507
GJ1209509
GJ1209510
GJ1209511
GJ1209513
GJ1209514
GJ1209516

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
Soredex DIGORA Optime X-Ray Imager PSU Insulation Recall
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