Z-1695-2017 Class II Terminated
FDA device recall Z-1695-2017 was initiated by Ion Beam Applications S.A. on March 9, 2017 and is designated Class II. Reason for recall: The Proton Therapy System can allow gantry rotation even if the snout is not properly locked. The recall status is terminated (terminated March 26, 2019). Affected quantity: 8 worldwide, 4 in U.S..
Recall Details
- Product Type
- Devices
- Report Date
- April 5, 2017
- Initiation Date
- March 9, 2017
- Termination Date
- March 26, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 worldwide, 4 in U.S.
Product Description
Proteus 235
Reason for Recall
The Proton Therapy System can allow gantry rotation even if the snout is not properly locked.
Distribution Pattern
Distributed in MA, FL, VA, and TN. China, South Korea, France and Germany
Code Information
Serial numbers: PAT.000, PAT.001, PAT.003, PAT.006, PAT.108, PAT.111, SAT.119, SAT.120