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Philips Electronics North America Corporation recalls Ingenia MR-OR; 781437, 781438 The MR-OR option is intended for allowing transfer of a neurosurgical patient from OR sui
Recalled December 28, 2016 · FDA recall Z-0825-2017 · Philips Electronics North America
Hazard
Possibility that a patient or user may be exposed to a very small level of touch current. · FDA Class II
Units
9
Sold at
Worldwide Distribution -US including CA, NY and Internationally to United Kingdom, Australia, Norway, and Thailand
Description
Possibility that a patient or user may be exposed to a very small level of touch current.
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
Manufacturer(s)
Philips Electronics North America Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →