X-ray System Models 706100 and 706110 Electrical Fire Risk from Power Surge
Philips ProxiDiagnost R90 X-ray systems may experience electrical fires if exposed to overvoltage or power surges. The recalled systems affect 243 units distributed nationwide and globally.
What this means for you
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: FDA Class II device with potential for electrical fire hazard from power surge exposure. No illnesses, injuries, or deaths have been reported; the hazard is based on the device's vulnerability to electrical fault conditions.
Plain-English summary
Philips North America LLC is recalling 243 units of the ProxiDiagnost R90 1.0 and 1.1 multi-functional general X-ray (R/F) systems, model numbers 706100 and 706110, distributed nationwide and globally.
The systems can experience a short circuit in the main cabinet if exposed to an overvoltage or power surge. If this occurs, users may observe an electrical fire within the cabinet, smoke emanating from the cabinet, or hear popping sounds.
Facilities using these systems should take immediate steps to protect equipment and personnel from potential electrical hazards. Contact Philips North America LLC for guidance on mitigation or replacement options.
The recalled product
- Product
- ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 706100 and 706110
- Manufacturer
- Philips North America Llc
- Affected units
- 243
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 (2)
- GTIN: (01)00884838085619 (Model 706100)
- (01)00884838103221 (Model 709031)
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Philips North America Llc 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.
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