Recall Z-2485-2023 ยท OWB Interventional Fluoroscopic X-Ray System
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems
| Date | Aug 30, 2023 (initiated Jun 30, 2023) |
| Status | Open, Classified |
| Reason | Loss of availability of the wireless foot switch during procedures. |
| Root cause | Under Investigation by firm |
| Action | 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 |
| Quantity | 1865 units |
| 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, Kor |
| FDA record | Open on fda.gov |