The Recall Desk
HighFDA (Devices)·Z-1355-2023·Announced 2023-04-19

Medical X-ray Systems Recalled for Electrical Fire Hazard

Philips CombiDiagnost R90 X-ray systems (Model Numbers 709030 and 709031) may experience electrical fire in the main cabinet if exposed to overvoltage or power surge.

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: This is a Class II medical device recall for a potential electrical fire hazard in X-ray imaging systems. The source text does not report any injuries or deaths, but the risk of electrical fire within the equipment cabinet represents a significant patient and facility safety concern.

Plain-English summary

Philips North America LLC is recalling CombiDiagnost R90 1.0 and 1.1 multi-functional radiography/fluoroscopy systems, Model Numbers 709030 and 709031. Approximately 512 units have been distributed nationwide in the United States and globally.

The systems can experience a short circuit condition in the main cabinet if exposed to an overvoltage or power surge. This could result in an electrical fire within the cabinet; users may see or smell smoke from the cabinet or hear popping sounds.

Healthcare facilities and other users of affected equipment should review the recall notice and serial number lists provided by the FDA to determine if their equipment is affected.

The recalled product

Product
CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031
Manufacturer
Philips North America Llc
Hazard
  • electrical-fire
  • power-surge
  • short-circuit

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)00884838076747 (Model 709030)
  • (01)00884838101456 (Model 709031

Distribution

Distributed nationwide across the United States.