Ingenuity TF PET/CT — Class II medical device recall Z-0897-2013
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2013-03-06, distributed in OH. The system may not default to the same gating trigger with which the data were acquired. This could cause a ri
| Recall number | Z-0897-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems (Cleveland) Inc, Cleveland, OH, United States |
| Recall initiated | 2013-01-21 |
| Classified | 2013-02-28 |
| Reported by FDA | 2013-03-06 |
| Terminated | 2013-07-19 |
| Distributed | OH |
| Quantity | 1 units |
| Serial numbers | 2004 |
| Model numbers | 882456 |
Product
Ingenuity TF PET/CT. Diagnostic imaging system
Reason for recall
The system may not default to the same gating trigger with which the data were acquired. This could cause a risk for patients.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0897-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.