Philips Wireless Foot Switch for X-Ray Systems Risks Loss of Function During Procedures
Philips is recalling wireless foot switches used with Allura Xper and Azurion X-ray systems because they may become unavailable during procedures. Approximately 1,865 units were distributed 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 device with potential for procedure disruption, but no reported injuries or illnesses. The hazard is loss of function during use—a risk-of-harm scenario without documented patient harm.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling wireless foot switches (Models 722001, 722003, 722005, and others) distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems. The affected devices may lose availability during clinical procedures.
The wireless foot switch is a control device used by operators during interventional fluoroscopic procedures. Loss of availability during a procedure could disrupt the intended operation of the X-ray system.
Approximately 1,865 units were distributed worldwide, including throughout the United States and to numerous countries in Europe, Asia, the Middle East, and other regions. The recall affects specific lot numbers provided in the FDA notice.
Healthcare facilities using affected systems should contact Philips Medical Systems Nederland B.V. for corrective action or replacement devices. Users should refer to the full FDA recall notice for detailed model numbers and lot information.
The recalled product
- Product
- Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Affected units
- 1,865
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)
- Model No.: 722001
- 722003
- 722005
- 722006
- 722008
- 722010
- 722011
- 722012
- 722013
- 722015
- 722023
- 722025
- 722026
- 722027
- 722028
- 722029
- 722033
- 722035
- 722038
- 722039
Distribution
Distributed nationwide across the United States.
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