Ion Beam Applications S.A. 2024-09-18 Health serious FDA
Health · FDA · Recall #FDA-Z-3089-2024
IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions:… Recall
Issued September 18, 2024 · Ion Beam Applications S.A.
In September 2024, Ion Beam Applications S.A. recalled the IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions:…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Safety Parameters Verification Mechanisms can be deactivated in clinical runtime
What you should do
- 1 Stop using IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions:… 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
- September 18, 2024
- Units affected
- Not reported
- Sold at
- Worldwide - US Nationwide distribution in the states of AK, NJ, PA, VA,OK,FL, KA, IL, LA, MI, TN , TX, VA and the countries of BE, CZ, DE, E
- Recall number
- FDA-Z-3089-2024
- 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 737th Health recall we've logged in 2024.