Siemens Medical Solutions USA, Inc 2022-01-05 Health serious FDA
Health · FDA · Recall #FDA-Z-0441-2022
ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and… Recall
Issued January 5, 2022 · Siemens Medical Solutions USA, Inc
In January 2022, Siemens Medical Solutions USA, Inc recalled the ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and…, 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 safety issue under specific preconditons that may result in a user selecting the wrong site for treatment with the possibility to deliver dose to the wrong isocenter which could result in serious patient injury
What you should do
- 1 Stop using ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and… 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
- January 5, 2022
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the states of IA, LA, NE, NJ, NV, NY, OH, PA, SC, SD.
- Recall number
- FDA-Z-0441-2022
- 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.