Siemens Medical Solutions USA, Inc 2022-07-13 Health serious FDA
Health · FDA · Recall #FDA-Z-1342-2022
Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600 Recall
Issued July 13, 2022 · Siemens Medical Solutions USA, Inc
In July 2022, Siemens Medical Solutions USA, Inc recalled the Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600, 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
During system tests, an increased wearing of the Image acquisition system fans has been observed. This could lead to an electrical failure which may cause malfunction of the image system during regular system operation.
What you should do
- 1 Stop using Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600 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
- July 13, 2022
- Units affected
- Not reported
- Sold at
- Domestic distribution to AL, AR, AZ, CA, CO, CT, DE, FL, ID, IL, IN, KY, LA, MA, MD, MI, MO, MT, NC, NE, NJ, NY, OH, PA, RI, SC, SD, TN, TX,
- Recall number
- FDA-Z-1342-2022
- 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.