Home / Recalls / PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. / Z-2485-2023

Z-2485-2023 Class II Ongoing

Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Best, N/A

FDA device recall Z-2485-2023 was initiated by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. on June 30, 2023 and is designated Class II. Reason for recall: Loss of availability of the wireless foot switch during procedures. The recall status is ongoing. Affected quantity: 1865 units.

Recall Details

Product Type: Devices
Report Date: September 6, 2023
Initiation Date: June 30, 2023
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1865 units

Product Description

Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems

Reason for Recall

Loss of availability of the wireless foot switch during procedures.

Distribution Pattern

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, Morocco, Netherlands, New Zealand, Norway, Oman, Palestine, State of, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tanzania, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, and Yemen.

Code Information

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.

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