The Recall Desk
HighFDA (Devices)·Z-1356-2023·Announced 2023-04-19

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
Category
Medical Device — Diagnostic Imaging / X-ray System
Hazard
  • electrical-fire
  • power-surge

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.

Related recalls

Same category