Recall Z-1056-2019 ยท OWB Interventional Fluoroscopic X-Ray System
Philips North America, LLC
URODiagnost Eleva, Product codes 708026, 708027, 708028 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ray system with remote-controlled facilities. It performs a wide range of routine examinations and interventional procedures include: Gastro-intestinal examination Urography Bronchography Arthrography Hysterography Myelography Lymphography Skeletal rad
| Date | Feb 28, 2019 |
| Status | Terminated |
| Reason | The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user. |
| Root cause | Component design/selection |
| Action | On February 28, 2019, the firm notified customers via an Urgent Field Safety Notice letter. The letter informed customers that the affected systems would be inspected for missing locking plates. Customers were asked to place a copy of the Field Safety Notice with the documentation of the system until the system has been inspected by Philips. Philips will inspect all potentially affected systems free of charge. If a locking plate is found missing, Philips will secure the system until a locking plate is installed so that use of the system can continue. You will be contacted by your local Phili |
| Quantity | 1969 |
| Distribution | US Nationwide domestic distribution, and worldwide international distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032046 | PHILLIPS OMNIDIAGNOST ELEVA Philips Medical Systems, Inc., Jul 17, 2003 |