FDA Enforcement
Class II
Ongoing
IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning System.
Recall: Z-0295-2024
·
Reported November 22, 2023
Enforcement
- Recall Number
- Z-0295-2024
- Event ID
- 93293
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Ion Beam Applications S.A.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 22, 2023
- Initiation Date
- September 18, 2023
- Classification Date
- November 14, 2023
- Address
- Chemin Du Cyclotron 3, N/A, Ottignies-Louvain-La-Neuve, N/A, N/A, Belgium
Description
IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning System.
Reason
The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices.
Code Info
UDI-DI: (01)05404013801138. Serial numbers (US): SAT133, SAT140, SBF113, SBF128, SBF135 & (OUS): SAT125, SAT127, SAT132, SAT136, SBF107, SBF112, SBF117, SBF124, & SBF125.
Distribution
Worldwide - US Nationwide distribution in the states of Arkansas, Florida, Kansas, and Virginia and the countries of Belgium, France, India, Italy, Netherlands, Spain, Singapore, and Taiwan.
Quantity
5 (US), 9 (OUS)