Recall Z-0984-2019 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Siemens Medical Solutions USA, Inc
Uroskop Omnia -fluoroscopic X-ray system Model # 10094910 The Uroskop Omnia is a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery).
| Date | Feb 8, 2019 |
| Status | Terminated |
| Reason | The swivel arm holding the monitors may become dislodged from the carrying arm. |
| Root cause | Device Design |
| Action | The firm, Siemens, issued an "URGENT: MEDICAL DEVICE CORRECTION "on 2/8/19 to its customers. The letter is identifying the problem, risk, actions to take and corrective action. The customers were instructed to do the following: Immediately examine your inventory and quarantine product subject to recall (if applicable). or To avoid the risk until implementation of the corrective action, it is strongly recommended not to move and position monitors above the system table. As an alternative and if clinically applicable, monitors can also be used when they are left in the parking position. In addit |
| Quantity | 6 |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101491 | UROSKOP OMNIA Siemens Medical Solutions USA, Inc., Jun 30, 2010 |