Device product
SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge
Z-1136-2023
Product summary
- Event
- Event 91518
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4 units
- Official record key
device-enforcement:Z-1136-2023
Official wording
Reason: This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.
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
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Japan, Chile, Australia.
Derived failure modes
-
Unknown
This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.