Recall Z-0825-2017— Philips Electronics North America Corporation

Name: FDA recall Z-0825-2017
Creator: U.S. Food and Drug Administration
Published: 2016-12-01

Class II · Terminated

Class II FDA medical device recall by Philips Electronics North America Corporation, initiated 2016-12-01, terminated 2017-08-31. It names one FDA 510(k) clearance: K110151. 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..

Recalling firm: Philips Electronics North America Corporation
Classification: Class II
Status: Terminated
Initiated: 2016-12-01
Terminated: 2017-08-31
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K110151 — ACHIEVA R4 1.5T AND ACHIEVA R4 3.0TPhilips Health Care·cleared 2011-03-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.