Reported Aug 14, 2024 · Ongoing
Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image.…
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 -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image
- Model Number10762472
- Lot codes and dates
- UDI(01)04056869009162(21) Serial Numbers; Serial Number
333 of 333 codes
641446105864374644136443364048644606438564036640136444864451644456405764205643266405564051642626428864338640616413164314643996403464443641056401964309643256123164032641706408864457644786410464244644496431664111642806423964241644206441264136642736411264247643296412464486641966432064388641476444664479
- UDI(01)04056869009162(21) Serial Numbers; Serial Number
- Amount recalled
- 333 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays
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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