Siemens Medical Solutions USA, Inc 2022-04-27 Health serious FDA
Health · FDA · Recall #FDA-Z-0978-2022
Artis Q.zen floor, Model Number 10848353 Recall
Issued April 27, 2022 · Siemens Medical Solutions USA, Inc
In April 2022, Siemens Medical Solutions USA, Inc recalled the Artis Q.zen floor, Model Number 10848353, 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
If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several minutes later the system will block X-ray to prevent further damage and display the message "NO XRAY: TUBE TOO HOT".
What you should do
- 1 Stop using Artis Q.zen floor, Model Number 10848353 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
- April 27, 2022
- Units affected
- Not reported
- Sold at
- US Nationwide.
- Recall number
- FDA-Z-0978-2022
- 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 870th Health recall we've logged in 2022.