FDA Device recall Z-0897-2013
Ingenuity TF PET/CT. Diagnostic imaging system
- FDA Device
- Class II
- terminated
- Published 2013-03-06
On 2013-03-06 the FDA classified a Class II recall of Ingenuity TF PET/CT. Diagnostic imaging system by Philips Medical Systems Cleveland, citing the system may not default to the same gating trigger with which the data were acquired. This could cause a risk for patients.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0897-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-01-21 |
| Published | 2013-03-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | OH |
Product
Ingenuity TF PET/CT. Diagnostic imaging system
Reason
The system may not default to the same gating trigger with which the data were acquired. This could cause a risk for patients.
Identifiers
| code_info | Model # 882456, Serial # 2004. Units currently running Ingenuity TF PET/CT system software version 4.0.0.26635. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0897-2013%22
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