Canon Medical System, USA, INC. 2022-07-06 Health serious FDA
Health · FDA · Recall #FDA-Z-1289-2022
System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: … Recall
Issued July 6, 2022 · Canon Medical System, USA, INC.
In July 2022, Canon Medical System, USA, INC. recalled the System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: …, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
CT operation may be restricted by an interlock which is a result of an system error and the CT system may stop operating properly after an attempt to cancel the error message has been initiated.
What you should do
- 1 Stop using System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: … right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Canon Medical System, 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
- Canon Medical System, USA, INC.
- Category
- Health
- Recall date
- July 6, 2022
- Units affected
- Not reported
- Sold at
- U.S.: CA, CO, FL, NY, and WY O.U.S.: None
- Recall number
- FDA-Z-1289-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Canon Medical System, USA, INC. has 2 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.