Ion Beam Applications S.A. 2022-06-08 Health serious FDA
Health · FDA · Recall #FDA-Z-1205-2022
Proteus235- Proton Therapy System: to produce and deliver a proton beam for the… Recall
Issued June 8, 2022 · Ion Beam Applications S.A.
In June 2022, Ion Beam Applications S.A. recalled the Proteus235- Proton Therapy System: to produce and deliver a proton beam for the…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning Magnet setpoints resulting in the field size may be smaller than expected and the irradiated area may receive more dose than prescribed
What you should do
- 1 Stop using Proteus235- Proton Therapy System: to produce and deliver a proton beam for the… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Ion Beam Applications S.A. 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
- Ion Beam Applications S.A.
- Category
- Health
- Recall date
- June 8, 2022
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide distribution in the states of IL, VA, WA and the country of Germany.
- Recall number
- FDA-Z-1205-2022
- Made in
- Belgium
- Issuing agency
- FDA
In context
- Ion Beam Applications S.A. 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.