Siemens Medical Solutions USA, Inc 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). Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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).
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
Serial Nos. 3417 3414 3415 3418 3428 3416
Products Sold
Serial Nos. 3417 3414 3415 3418 3428 3416
Siemens Medical Solutions USA, Inc is recalling Uroskop Omnia, Model no. 10094910 - Product Usage: a solid state detector fluoroscopic X-ray system, due to 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 mo. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026