FDA Device recall Z-1134-2023
SIEMENS Biograph Horizon 3R Mobile
- FDA Device
- Class II
- ongoing
- Published 2023-02-22
On 2023-02-22 the FDA classified a Class II recall of SIEMENS Biograph Horizon 3R Mobile 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-1134-2023 |
| 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 Horizon 3R Mobile; System, Tomography, Computed, Emission
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 | UDI/DI 405686901102894792, Material Number 10532746, Serial Number 94792 |
|---|
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-1134-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.