Ingenia MR-OR — Class II medical device recall Z-0825-2017
Terminated recall by Philips Electronics North America Corporation, reported 2016-12-28, distributed in CA, NY. Possibility that a patient or user may be exposed to a very small level of touch current.
| Recall number | Z-0825-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Electronics North America Corporation, Andover, MA, United States |
| Recall initiated | 2016-12-01 |
| Classified | 2016-12-19 |
| Reported by FDA | 2016-12-28 |
| Terminated | 2017-08-31 |
| Distributed | CA, NY |
| Countries outside the US | AU, GB, NO, TH |
| Quantity | 9 |
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 for recall
Possibility that a patient or user may be exposed to a very small level of touch current.
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-0825-2017. 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.