Reported Mar 1, 2023 · Ongoing
Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model…
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 · 19355-1418
Is this the product you have?
- Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for radiographic
- and fluoroscopic studie Model Number10762473
- Lot codes and dates
- UDI4056869008981
- S/N4645 4556 4510 5144 4307 4594 4125
- Expanded Recall 2/24/23
215 of 215 codes
401440154020402240324033404240474055405940614062406340674068408640944096409941024105410641084111411241144117411941204126412841294130413241344135413641414142414643034305430643104312431443164318431943254326432943304332450045014509451345164519
- Amount recalled
- 7 units; Exanded recall: 215 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values
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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