Recall Z-0805-2021
Siemens Medical Solutions USA, Inc · initiated September 9, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Uroskop Omnia, Model no. 10094910 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery).
Codes / lots: Serial Nos. 3417 3414 3415 3418 3428 3416
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.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-0805-2021
- Initiated
- September 9, 2020
- Terminated
- April 16, 2021
- Product code
- JAA – System, X-Ray, Fluoroscopic, Image-Intensified
- Quantity
- 6
- Distribution
- Worldwide distribution.
- Recalling firm
- Siemens Medical Solutions USA, Inc, Malvern, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0806-2021 Class II | Uroskop Omnia Max, Model no. 10762473 - Product Usage: a solid state detector…After the March 2019 corrective action on the monitor support arm, there is a residual risk of the support… | 09/09/2020Terminated |