Z-1136-2023 Class II Ongoing
FDA device recall Z-1136-2023 was initiated by Siemens Medical Solutions USA, Inc. on January 16, 2023 and is designated Class II. Reason for recall: This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position. The recall status is ongoing. Affected quantity: 4 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 22, 2023
- Initiation Date
- January 16, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 units
Product Description
SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge
Reason for Recall
This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Japan, Chile, Australia.
Code Information
a) 450: UDI/DI 405686923807410106, Material Number 10749669, Serial Number 10106; b) 600: UDI/DI 405686922450311120, Material Number 10749670, Serial Number 11120; UDI/DI 405686922450311116, Material Number 10749670, Serial Number 11116; c) 600 Edge: UDI/DI 405686918321311068, Material Number 10749672, Serial Number 11068