Ingenuity TF PET/MR — Class II medical device recall Z-2491-2015
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2015-09-09, distributed in NY, OH, TX. Philips Healthcare has become aware of a problem in which the Ingenuity TF PET/MR PET Reconstruction Server (P
| Recall number | Z-2491-2015 |
|---|---|
| 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 | 2015-07-23 |
| Classified | 2015-08-31 |
| Reported by FDA | 2015-09-09 |
| Terminated | 2018-06-26 |
| Distributed | NY, OH, TX |
| Countries outside the US | CH, DE, ES, FI, HK, JP, KR, NL |
| Quantity | 11 |
Product
Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems
Reason for recall
Philips Healthcare has become aware of a problem in which the Ingenuity TF PET/MR PET Reconstruction Server (PRS) database may lock up after an MR acquisition is completed and before a PET acquisition is begun, even though no actual database lockup issue has been reported in the field-installed Ingenuity TF PET/MR systems.
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-2491-2015. 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.