Ingenuity TF PET/CT — Class II medical device recall Z-1029-2013
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2013-04-10, distributed in OH. Issues have been detected in the Ingenuity TF PET/CT currently running software version 4.0.60605.0 that if th
| Recall number | Z-1029-2013 |
|---|---|
| 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 | 2012-12-20 |
| Classified | 2013-04-01 |
| Reported by FDA | 2013-04-10 |
| Terminated | 2013-06-18 |
| Distributed | OH |
| Quantity | 1 |
| Reason classes | software |
| Serial numbers | 2004 |
| Model numbers | 882456 |
Product
Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
Reason for recall
Issues have been detected in the Ingenuity TF PET/CT currently running software version 4.0.60605.0 that if they were to re-occur, could cause a risk for patients, users or service personnel, including inaccurate standard uptake values (SUV). Philips Medical Systems (Cleveland), Inc. is issuing a software update to address the issues.
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-1029-2013. 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.