Severe FDA (Devices)·Z-0841-2020·Announced 2020-01-29

KaVo Scan eXam X-Ray Imager Recalled for Power Supply Fire Risk

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.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a risk of heating, melting, and smoke generation from a power supply unit, which constitutes a significant injury or property-damage risk (fire hazard) under the rubric for Severe recalls.

Plain-English summary

Palodex Group Oy is recalling the KaVo Scan eXam SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) due to a defect in the power supply unit (PSU). The recall affects 4,563 units distributed globally, including in the United States (Wisconsin and Pennsylvania) and numerous international locations.

The recall is necessary because slow degradation of the plastic insulation used in the PSU DC plug may result in short circuiting. This short circuiting may cause heating and melting, which can generate smoke and eventually cause the power supply to fail. The affected units are identified by serial numbers ranging from KJ1208178 to KJ1314403, and PSU serial numbers beginning with 1143, 1221, 1224, or 1229.

Healthcare facilities and users of these devices should contact Palodex Group Oy for instructions on how to address the defect. The source text does not specify a particular action such as stopping use, but users should follow the manufacturer's guidance to mitigate the risk of heating and smoke generation.

The recalled product

Product: KaVo Scan eXam 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: 4,563

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
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

Same hazard · fire