Ingenuity TF Positron Emission Tomography — Class II medical device recall Z-1682-2015
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2015-06-03, distributed in NY, OH, TX. It was noticed that the spectroscopy voxel map did not align with the anatomical images of the phantom. This r
| Recall number | Z-1682-2015 |
|---|---|
| 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 | 2015-03-11 |
| Classified | 2015-05-28 |
| Reported by FDA | 2015-06-03 |
| Terminated | 2018-06-26 |
| Distributed | NY, OH, TX |
| Countries outside the US | CH, DE, ES, FI, JP, KR, NL |
| Quantity | 10 units |
| Reason classes | chemical contamination |
| Serial numbers | 11005, 11006, 11007, 11008, 11009, 11010, 11011, 11012, 11013, 11014, 24061 |
Product
Ingenuity TF Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI), 882380, Philips Medical Systems. The device is a diagnostic imaging system for fixed installations that combines Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI).
Reason for recall
It was noticed that the spectroscopy voxel map did not align with the anatomical images of the phantom. This resulted in incorrect orientation of the Chemical Shift Imaging (CSI) data.
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-1682-2015. 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.