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.
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 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.
- Hazard
- device-malfunction
- radiation-safety-risk
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.
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