The Recall Desk
SevereFDA (Devices)·Z-0842-2020·Announced 2020-01-29

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.

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 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
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 →