Recall Z-1333-2020 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
Uroskop Omnia max, Model No. 10762473 - Product Usage: Uroskop Omnia Max is a device intended to visualize anatomical structures by converting an Xray pattern into a visible image. The system is designed primarily for urological diagnosis and the support of urological therapeutic applications such as examinations and small interventions of the urogenital tract.
| Date | Jan 8, 2020 |
| Status | Terminated |
| Reason | Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in collision control creating risk of collision with obstacles or persons when the operator uses the override function. |
| Root cause | Use error |
| Action | On January 8, 2020, the firm initiated the recall, notifying customers via Urgent Medical Device Correction letters. Customers were advised of the potential for a system collision due to incorrect use of the bypass key overriding the built-in collision control. The bypass key is intended to enable movement of an otherwise blocked system to avert immediate hazard, e.g. to recover a patient following device error or in case of emergency. It is not intended for permanent use. Customers were instructed to use the bypass key exclusively to avert an immediate hazard and immediately contact Siemens |
| Quantity | 192 |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173639 | Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax Siemens Medi Cal Solutions, Inc., Apr 2, 2018 |