FDA Device recall Z-0825-2017
Ingenia MR-OR
- FDA Device
- Class II
- terminated
- Published 2016-12-28
On 2016-12-28 the FDA classified a Class II recall of Ingenia MR-OR by Philips Electronics North America, citing possibility that a patient or user may be exposed to a very small level of touch current.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0825-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-01 |
| Published | 2016-12-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Electronics North America |
| Distribution | CA, NY |
Product
Ingenia MR-OR; 781437, 781438 The MR-OR option is intended for allowing transfer of a neurosurgical patient from OR suite to MR suite and back with tools and instructions for proper positioning and MR imaging of those patients. MR-OR option also facilitates execution of simple neurosurgical procedures in the near proximity of the MR scanner without a need to move the patient back to the OR suite
Reason
Possibility that a patient or user may be exposed to a very small level of touch current.
Identifiers
| code_info | 781437: 15001, 15002, 15003 781438: 30001, 30002, 30003, 30004, 30005, 30006 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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All Philips Electronics North America recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0825-2017%22
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