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…

Recall date

December 1, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0825-2017

FDA classification

Class II

Brand / firm

Philips Electronics North America Corporation

Sold / distributed

Worldwide Distribution -US including CA, NY and Internationally to United Kingdom, Australia, Norway, and Thailand

Why it was recalled

Possibility that a patient or user may be exposed to a very small level of touch current.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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