Uroskop Omnia Max, Model no. 10762473 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery).
FDA Recall Z-0806-2021 · Posted None
Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeJAA
Date Initiated2020-09-09
Date Terminated2021-04-16
Product Quantity281
Reason for Recall
After the March 2019 corrective action on the monitor support arm, there is a residual risk of the support arm becoming dislodged in cases when the monitor support arm is used intensely over a long period of time.
Firm Action
On September 9, 2020, the firm distributed Urgent Medical Device Correction letters to affected customers. Customers were informed that the firm has released an additional safety measure to avoid the potential issue. A safety gear will be installed into the monitor support arm out of an abundance of caution. The corrective action is available and is being provided to affected users free of charge.
The firm will contact customers to arrange a date to perform the corrective action. Please feel free to contact the firm to schedule an earlier appointment at 1-800-888-7436.
Root Cause
Device Design
Distribution Pattern
Worldwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.