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.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Affected units
- 4,563
Distribution
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 →Related recalls
Same manufacturer · Palodex Group Oy
See all →- HighDental X-Ray Device Testing Defect May Affect Image Repeatability
FDA (Devices) · 2024-08-21
- HighSoredex DIGORA Optime X-Ray Imager PSU Insulation Recall
FDA (Devices) · 2020-01-29
- HighGendex X-Ray Imager Recall Due to Power Supply Insulation Degradation
FDA (Devices) · 2020-01-29
- SeverePalodex Dental X-Ray Imagers Recalled for Power Supply Fire Risk
FDA (Devices) · 2020-01-29
Same hazard · fire
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- Severe
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