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FDA (Device enforcement)Recalled 2023-06-30class ii

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems

Hazard

Loss of availability of the wireless foot switch during procedures.

Details from the source

Reason for recall: Loss of availability of the wireless foot switch during procedures. Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Bosnia and Herzegovina, Brazil, Chile, China, Croatia, Czech Republic, Denmark, Egypt, Fiji, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Kosovo, Latvia, Lebanon, Libya, Malaysia, Maldives, Malta, Martinique, Mexico, Moro Quantity: 1865 units Lot/code info: Model No.: 722001, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722015, 722023, 722025, 722026, 722027, 722028, 722029, 722033, 722035, 722038, 722039, 722058, 722059, 722064, 722065, 722066, 722067, 722068, 722078, 722079; No UDI-DI; Lot No. 459800772231, 459800772233, 459800772261, 459800772263, 459800415531,459800415532, 459800415533, 459800415534, 459800415535, 459800415571, 459800415572, 459800415573, 459800415574, 459800415575.

UPC codes

459800772231, 459800772233, 459800772261, 459800772263, 459800415531, 459800415532, 459800415533, 459800415534, 459800415535, 459800415571, 459800415572, 459800415573, 459800415574, 459800415575

Source

Official record: FDA (Device enforcement)

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

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