Reported Mar 1, 2023 · Ongoing
Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoroscopic studies. Model Number:…
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?
- Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoroscopic studies
- Model Number10502200
- Lot codes and dates
- UDIN/A
- S/N60040 60018 60223 60015
- Expanded Recall 2/24/23S/N:
93 of 93 codes
600116003760041600436005160055600566006260067600716007260075600766008160087600896009260093600956010360111601146011860133601386014060141601436014660155601626017160172601736017860183601846018660187601886019260194601966020460208602146021960220602216022560227602286023060231602346023860239602556025960262
- Amount recalled
- 4 units. Expanded Recall: 93 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.
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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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