Agency classClass IIOur severity:High FDA (Devices)·Z-2587-2023·Announced 2023-09-20

Philips X-Ray Systems Recalled for Foot Switch Malfunction Risk

Philips Allura and Azurion x-ray imaging systems are being recalled due to a damaged foot switch component that may prevent or intermittently disable x-ray radiation initiation. Approximately 19,115 systems are affected worldwide.

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: FDA Class II medical device recall. No illnesses or injuries reported, making the hazard theoretical. However, this qualifies as a risk-of-harm product (potential x-ray initiation failure in critical diagnostic equipment) where injury has not yet been reported, warranting a High severity score per rubric criteria.

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva imaging systems due to a damaged foot switch component. The foot switch controls x-ray radiation initiation, and when damaged, may result in instances where no radiation or only intermittent radiation can be produced.

The recall affects approximately 19,115 systems distributed worldwide across multiple product lines. Affected models include the 708000 series and numerous 722000-series variants.

Healthcare facilities operating these systems should verify the integrity of the foot switch component and contact Philips Medical Systems for replacement or repair instructions. No illnesses or injuries have been reported to date, though the malfunction could impact diagnostic imaging capability.

The recalled product

Product: Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems
Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category: Medical Device — Diagnostic Imaging / X-Ray Equipment
Hazard: device-malfunction
radiation-safety-risk
Affected units: 19,115

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 (20)

Models: 708032
708034
708036
708037
708038
722001
722002
722003
722005
722006
722008
722010
722011
722012
722013
722015
722019
722020
722022
722023

Distribution

Distribution scope not specified by the agency.

Same manufacturer · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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