Philips Medical Systems is recalling approximately 1,865 Wireless Foot Switches used with Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems. The recall was initiated because these wireless foot switches may lose connection and become unavailable during medical procedures. This defect can lead to delays in surgical or diagnostic procedures while staff switch to backup controls or troubleshoot the connection. Affected units include 29 different model numbers and specific lot numbers distributed worldwide between June 2023 and August 2023.
If the wireless foot switch loses connectivity during a procedure, the physician may be unable to control the X-ray system, potentially resulting in procedural delays or the need for emergency transitions to secondary controls while a patient is undergoing treatment.
Manufacturer instructions and support
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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