Agency classClass IIOur severity:High FDA (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.

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 3/5 (High).

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
Category: Medical Device — Radiography / Fluoroscopy System
Hazard: electrical-fire
power-surge
short-circuit
Affected units: 512

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.

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.

See all 2 products in this recall →

Same manufacturer · Philips North America Llc

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Same hazard · electrical fire