Reported Jan 20, 2021 · Terminated
Uroskop Omnia, Model no. 10094910 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for…
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355
Is this the product you have?
- Uroskop Omnia, Model no. 10094910 -
- Product Usagea solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery)
- Lot codes and dates
- Serial Nos. 3417 3414 3415 3418 3428 3416
- Amount recalled
- 6
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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