FDA Device recall Z-0893-2022
Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems
- FDA Device
- Class II
- terminated
- Published 2022-04-13
On 2022-04-13 the FDA classified a Class II recall of Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems by Siemens Medical Solutions Usa, citing there is a quality issue with the three bolts that hold the CT balancing weights, which could create a safety issue.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0893-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-03-11 |
| Published | 2022-04-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | n/a |
Product
Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems
Reason
There is a quality issue with the three bolts that hold the CT balancing weights, which could create a safety issue.
Identifiers
| code_info | A) Symbia Intevo Bold system; Model Number 11007962; Serial Numbers: 1) 1499 (UDI:40568690011591499) 2) 1501(UDI: 405…A) Symbia Intevo Bold system; Model Number 11007962; Serial Numbers: 1) 1499 (UDI:40568690011591499) 2) 1501(UDI: 40568690011591501) 3) 1505 (UDI: 40568690011591505) 4) 1510 (UDI: 40568690011591510) B) Symbia Intevo 6 system; Model Number 10764803; Serial Numbers: 1) 2352 (UDI: 40568690012342352) 2) 2353 (UDI: 40568690012342353) 3) 2354 (UDI: 40568690012342354) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0893-2022%22
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