Luminos Agile Max (VE10, VF10, VF11) Recall
Issued May 31, 2023 · Siemens Medical Solutions USA, Inc
In May 2023, Siemens Medical Solutions USA, Inc recalled the Luminos Agile Max (VE10, VF10, VF11), a serious health recall reported by the FDA. Affected owners are eligible for a fda mandated. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient reference point, according to IEC 60601-2-43. There is no impact on workflow or diagnosis. The error can occur only in fluoroscopy systems with a second (overhead) X-ray tube. Siemens Healthineers became aware of one customer site where this issue was identified during clinical operation.
What you should do
- 1 Stop using Luminos Agile Max (VE10, VF10, VF11) right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Siemens Medical Solutions USA, Inc to arrange your fda mandated. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Recall details
- Brand
- Siemens Medical Solutions USA, Inc
- Category
- Health
- Recall date
- May 31, 2023
- Units affected
- Not reported
- Sold at
- US Nationwide - Worldwide Distribution
- Recall number
- FDA-Z-1479-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Siemens Medical Solutions USA, Inc has 17 recalls in our database, including 2 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.