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).
Recall
- Recall Number
- Z-0806-2021
- Event Number
- 86985
- Firm
- Siemens Medical Solutions USA, Inc
- FEI Number
- 2240869
- Product Code
- JAA
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- September 9, 2020
- Terminated
- April 16, 2021
- Address
- 40 Liberty Blvd, Malvern, PA, 19355
Description
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).
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.
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.
Worldwide distribution.
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