Siemens Medical Solutions USA, Inc 2023-03-01 Health serious FDA
Health · FDA · Recall #FDA-Z-1167-2023
Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for … Recall
Issued March 1, 2023 · Siemens Medical Solutions USA, Inc
In March 2023, Siemens Medical Solutions USA, Inc recalled the Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for …, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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
What you should do
- 1 Stop using Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for … right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Siemens Medical Solutions USA, Inc to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Siemens Medical Solutions USA, Inc
- Category
- Health
- Recall date
- March 1, 2023
- Units affected
- Not reported
- Sold at
- US Nationwide distribution.
- Recall number
- FDA-Z-1167-2023
- 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.