Recall Z-0717-2018 ยท OWB Interventional Fluoroscopic X-Ray System
Philips Electronics North America Corporation
Allura Xper FD and and Xper FD ORT - Philips X-ray Systems Product Usage: The Allura Xper FD10 and Alllura Xper FD10/10 is intendd for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP). The Allura Xper FD20, Allura Xper FD20/10, Allura Xper
| Date | Dec 20, 2017 |
| Status | Terminated |
| Reason | Extra monitors, so called 7th or 8th monitor, mounted on the Monitor Ceiling Suspension (MCS), might disengage from the MCS and fall down. The two small set screws securing the two gliding rods into an aluminum block of the support arm can come loose because of vibrations and forces exerted on them. If the set screws have come loose gravity can keep the rods in position. However, if a force is exerted on the monitor pushing it forward, the monitor can topple forward. Once the monitor has toppled over it is only attached with its wires. If the monitor breaks loose of its wires it will drop on |
| Root cause | Device Design |
| Action | Philips sent an Urgent Field Safety Notice letter December 20, 2017 dated to all affected customers. The letter identified the affected product, problem and the actions to be taken. For question contact your local Philips representative. |
| Quantity | 1486 |
| Distribution | Worldwide Distribution - US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141979 | ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES Philips Medical Systems Netherland BV, Aug 19, 2014 |