Z-0930-2018 Class II Terminated
FDA device recall Z-0930-2018 was initiated by Ion Beam Applications S.A. on October 17, 2017 and is designated Class II. Reason for recall: IBA identified incorrect screw holes depth in graphite block 8 with respect to the degrader The recall status is terminated (terminated March 29, 2019). Affected quantity: 3.
Recall Details
- Product Type
- Devices
- Report Date
- March 14, 2018
- Initiation Date
- October 17, 2017
- Termination Date
- March 29, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3
Product Description
Proteus 235, graphite block 8
Reason for Recall
IBA identified incorrect screw holes depth in graphite block 8 with respect to the degrader
Distribution Pattern
WA
Code Information
PAT.115, SAT.116