Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems
This recall is currently active, issued September 14, 2023. It was issued by Philips Medical Systems Nederland B.V. Veenpluis 4-6 Best Netherlands.
- Recall Initiated
- August 15, 2023
- Posted
- September 14, 2023
- Recall Number
- Z-2587-2023
- Quantity
- 19,115 systems
- Official Source
- View on FDA website ↗
Reason for Recall
A damaged foot switch may cause instances where no or only intermittent x-ray radiation initiation is possible.
Distribution
Worldwide distribution
Lot / Code Info
Models: 708032, 708034, 708036, 708037, 708038, 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722015, 722019, 722020, 722022, 722023, 722025, 722026, 722027, 722028, 722029, 722031, 722033, 722035, 722038, 722039, 722058, 722059, 722063, 722064, 722065, 722066, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228, 722280, 722400 No UDI-DI information for foot switch component.
Root Cause
Device Design
Action Taken
US customers were notified via certified mail via USPS. OUS customers were notified through the Philips Markets Organizations. Philips is issuing two Urgent Medical Device Correction letters, one for Allura and Azurion customers and another one for MultiDiagnost Eleva Customers. Additionally, an IFU addendum will be provided to customers that includes instructions on how to handle the footswitch cable. For Allura and Azurion customers an updated preventative maintenance manual update is also being provided. Philips will contact customers to schedule a visit to inspect the foot switch and to provide an IFU Addendum.