FDA Device recall Z-1682-2015
Ingenuity TF Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI), 882380, Philips Medical Systems
- FDA Device
- Class II
- terminated
- Published 2015-06-03
On 2015-06-03 the FDA classified a Class II recall of Ingenuity TF Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI), 882380, Philips Medical Systems by Philips Medical Systems Cleveland, citing 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)….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1682-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-11 |
| Published | 2015-06-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | NY, OH, TX |
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
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.
Identifiers
| code_info | Serial #'s: 11005, 11006, 11007, 11008, 11009, 11010, 11011, 11012, 11013, 11014 & 24061. |
|---|
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-1682-2015%22
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