Recall Z-2757-2020 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Siemens Medical Solutions USA, Inc
SIEMENS Healthineers Uroskop Omnia max Model: 10762473 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
| Date | Jan 8, 2020 |
| Status | Terminated |
| Reason | Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max systems may cause collision of the system under operator control with obstacles or persons .(2) Incorrectly assigned image affecting Ysio Max, Luminos dRF Max and Luminos Agile Max systems with detector MAX Static causing incorrect base for diagnosis |
| Root cause | Device Design |
| Action | Siemens Medical Solutions USA, Inc. has initiated a Customer Safety Advisory Notice to all affected customers via XP028/19/S January 2020. Additionally, a solution to eliminate the root cause of this problem is being distributed via XP008/20/S March 2020. Following the corrective action, the cause is eliminated and a recurrence of the fault is prevented. New corrective software VE10Y became available June 22, 2020, and it is being distributed via an Update Instruction XP008/20/S. This update fixes the initial reported issue and the sporadic image loss issue noted by customers who had already |
| Quantity | 194 units |
| 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 |