Reported Mar 1, 2023 · Ongoing
Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studies…
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 Max with software VE10 & VF11- A diagnostic imaging system for radiographic
- and fluoroscopic studies Model Number10762472
- Lot codes and dates
- UDIN/A Serial Number
61624616526165963243633446414561664616416163161148611716122461776611866101461189611426171861036618576326861775610786121661818616296106763350
- Expanded Recall 2/24/23
406 of 406 codes
610176102161031610336103461037610386104061041610456104761055610576105961063610656107361074610756107761083610946109661097610986109961100611016110261112611186112061123611256112661129611306113161132611336114361152611536115761158611606116461165611666116861172611746117561177611786118461185611916119361195
- UDIN/A Serial Number
- Amount recalled
- 28 units. Expanded Recall: 506 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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