Recall Z-0922-2017 ยท OWB Interventional Fluoroscopic X-Ray System
Philips Electronics North America Corporation
Allura Xper FD20 722012 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).
| Date | Jan 20, 2017 (initiated Dec 1, 2016) |
| Status | Terminated |
| Reason | Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled. |
| Root cause | Process control |
| Action | Customers were notified of the recall via letter sent on 12/1/16. The letter explains the issue and the action that Philips plans to take. |
| Quantity | 1 |
| Distribution | US: WA OUS: China, Spain, Korea, Republic of, Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033737 | ALLURA XPER FD20 Philips Medical Systems North America, Inc., Dec 9, 2003 |