Z-1603-2024 Class II Ongoing
FDA device recall Z-1603-2024 was initiated by Ion Beam Applications S.A. on March 4, 2024 and is designated Class II. Reason for recall: There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance. The recall status is ongoing. Affected quantity: 8 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 1, 2024
- Initiation Date
- March 4, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 units
Product Description
IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
Reason for Recall
There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.
Distribution Pattern
US Nationwide distribution in the states of AR, FL, LA, KS, MI, TX, VA.
Code Information
PTS-10 versions, PTS-11 versions, and PTS-12 versions. UDI-DI: 05404013801138; Serial Numbers: SAT.123, SAT.126, SAT.133, SAT.140, SBF.105, SBF.113, SBF.128, SBF.135. All configurations.