Elekta, Inc. 2023-12-13 Health serious FDA
Health · FDA · Recall #FDA-Z-0445-2024
ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy… Recall
Issued December 13, 2023 · Elekta, Inc.
In December 2023, Elekta, Inc. recalled the ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.
What you should do
- 1 Stop using ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Elekta, 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
- Elekta, Inc.
- Category
- Health
- Recall date
- December 13, 2023
- Units affected
- Not reported
- Sold at
- worldwide
- Recall number
- FDA-Z-0445-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Elekta, Inc. has 5 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.