Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems
This recall is currently active, issued August 30, 2023. It was issued by Philips Medical Systems Nederland B.V. Veenpluis 4-6 Best Netherlands.
- Recall Initiated
- June 30, 2023
- Posted
- August 30, 2023
- Recall Number
- Z-2485-2023
- Quantity
- 1865 units
- Official Source
- View on FDA website ↗
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, 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.
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.
Root Cause
Under Investigation by firm
Action Taken
Customers were sent an URGENT Medical Device Correction letter dated 6/23/2023 via USPS Certified Mail. Customers are instructed to ensure that the wired footswitch is always connected to the system in case the wireless foot switch becomes unavailable. Customers are instructed to download a copy of the addendum to the IFU for the wireless foot switch and the Quick Reference Card at Http://philips.com/doc_library, and distribute these materials to those who use the system and retain a copy with the system's IFU. These documents are to be placed in an area where they are likely to be seen/viewed with system documentation. Customers are to return the attached response form to Philips no later than 30 days from receipt of the notification to IGT_Recalls@philips.com. Philips will contact customers to schedule a Field Service Engineer visit to confirm that the wired foot switch is connected to affected systems, perform a check of the charger, and provide customers with a hardcopy of the addendum. Customers with questions can contact Philips Technical Support Line at 1-800-722-9377.