Siemens Medical Solutions USA, Inc 2022-01-19 Health serious FDA
Health · FDA · Recall #FDA-Z-0474-2022
SOMATOM Edge Plus-Computed tomography system Model 1026700 Recall
Issued January 19, 2022 · Siemens Medical Solutions USA, Inc
In January 2022, Siemens Medical Solutions USA, Inc recalled the SOMATOM Edge Plus-Computed tomography system Model 1026700, 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
Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
What you should do
- 1 Stop using SOMATOM Edge Plus-Computed tomography system Model 1026700 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 19, 2022
- Units affected
- Not reported
- Sold at
- US Nationwide distribution.
- Recall number
- FDA-Z-0474-2022
- 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.