Siemens Medical Solutions USA, Inc. 2023-08-09 Health serious FDA
Health · FDA · Recall #FDA-Z-2256-2023
The following Pro.specta Emission Computed Tomography Systems that were manufactured with… Recall
Issued August 9, 2023 · Siemens Medical Solutions USA, Inc.
In August 2023, Siemens Medical Solutions USA, Inc. recalled the The following Pro.specta Emission Computed Tomography Systems that were manufactured with…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
During a whole-body planar scan with auto-contour, there is a possibility the short-linear drive (SLD) look-ahead sensors may trigger earlier than expected and may result in detector 1 positioning further from the patient than needed leading to a reduction in image resolution.
What you should do
- 1 Stop using The following Pro.specta Emission Computed Tomography Systems that were manufactured with… 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
- August 9, 2023
- Units affected
- Not reported
- Sold at
- Distribution was made to ID, KS, MA, NH, OH, TX, and VA. There was no government/military distribution. Foreign distribution was made to A
- Recall number
- FDA-Z-2256-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Siemens Medical Solutions USA, Inc. has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.