PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems

Hazard

A damaged foot switch may cause instances where no or only intermittent x-ray radiation initiation is possible.

Details from the source

Reason for recall: A damaged foot switch may cause instances where no or only intermittent x-ray radiation initiation is possible. Distribution: Worldwide distribution Quantity: 19,115 systems 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.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.