Palodex Dental X-Ray Imagers Recalled for Power Supply Fire Risk
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.
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 fire and smoke generation due to electrical short circuiting and melting, which meets the criteria for significant injury or property damage reports under the Severe category.
Plain-English summary
Palodex Group Oy is recalling the Instrumentarium Dental Express 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 issued 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 PSU to fail. The affected serial numbers range from IJ1208217 to IJ1313309, and specific PSU serial numbers begin with 1143, 1221, 1224, or 1229.
Consumers and healthcare providers should stop using the affected devices and contact Palodex Group Oy for further instructions on repair or replacement.
The recalled product
- Product
- Instrumentarium Dental Express SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
- Manufacturer
- Palodex Group Oy
- Category
- Medical Device — Dental Imaging
- 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
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