FDA Device recall Z-2491-2015
Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems
- FDA Device
- Class II
- terminated
- Published 2015-09-09
On 2015-09-09 the FDA classified a Class II recall of Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems by Philips Medical Systems Cleveland, citing 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 bef….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2491-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-23 |
| Published | 2015-09-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | NY, OH, TX |
Product
Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems
Reason
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.
Identifiers
| code_info | M/N 882380; S/N: 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-2491-2015%22
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