Recall archive / FDA device enforcement
Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems — FDA record Z-0893-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 11, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Quantity
- 7 devices
- Agency-reported status
- Terminated
- Source record identifier
- Z-0893-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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) |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distribution OUS only to El Salvador, France, Germany, Japan, Taiwan, and UK.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Apr 13, 2022
- Recall initiation date
- Mar 11, 2022
- Center classification date
- Apr 7, 2022
- Termination date
- Apr 14, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.