FDA Device recall Z-1136-2023
SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge
- FDA Device
- Class II
- ongoing
- Published 2023-02-22
On 2023-02-22 the FDA classified a Class II recall of SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge by Siemens Medical Solutions Usa, citing this is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1136-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-01-16 |
| Published | 2023-02-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge
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.
Identifiers
| code_info | a) 450: UDI/DI 405686923807410106, Material Number 10749669, Serial Number 10106; b) 600: UDI/DI 405686922450311120,…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1136-2023%22
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