Moderate FDA (Devices)·Z-0825-2017·Announced 2016-12-28

Philips Ingenia MR-OR Recalled for Potential Touch Current Exposure

Philips is recalling nine Ingenia MR-OR units due to a possibility that patients or users may be exposed to a very small level of touch current.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text describes the hazard as a 'very small level of touch current' without reporting any injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Philips Electronics North America Corporation is recalling nine units of the Ingenia MR-OR option, identified by codes 781437 and 781438. This medical device is intended for transferring neurosurgical patients between operating rooms and MRI suites and facilitating simple neurosurgical procedures near the scanner.

The recall was initiated because of the possibility that a patient or user may be exposed to a very small level of touch current. The affected units were distributed worldwide, including in the United States (California and New York) and internationally to the United Kingdom, Australia, Norway, and Thailand.

Healthcare facilities should contact Philips to determine if their units are affected and to arrange for the necessary corrective actions.

The recalled product

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 n
Manufacturer: Philips Electronics North America Corporation
Category: Medical Device — MRI System
Hazard: electric-shock
Affected units: 9

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

781437: 15001
15002
15003 781438: 30001
30002
30003
30004
30005
30006

Distribution

Distributed in 2 states:

Same manufacturer · Philips Electronics North America Corporation

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Same hazard · electric shock