Recall Z-0353-2025 ยท OWB Interventional Fluoroscopic X-Ray System
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Zenition 70, Model Number: 718133
| Date | Nov 12, 2024 (initiated Oct 7, 2024) |
| Status | Open, Classified |
| Reason | Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure. |
| Root cause | Under Investigation by firm |
| Action | On October 7, 2024 URGENT MEDICAL DEVICE CORRECTION letters were sent to consignees. 4. Actions that should be taken by the customer! user in order to prevent risks for patients. " Affected systems may continue to be used in accordance with their intended use and Instructions for Use (IFU). " Establish emergency protocols including back up devices if available in place to manage the situation should you experience this issue during the procedure. " Circulate this Urgent Medical Device Correction to all users of the system so that they are aware of the issue. " Keep this Urgent Medical Device C |
| Quantity | 2,247 units (582 US, 84 Canada, 1,581 R.O.W.) |
| Distribution | Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Isla |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K212813 | Zenition 70 Philips Medical Systems Nederland B.V., Oct 1, 2021 |