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Terminated

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

FDA Recall Z-0825-2017 · Posted 2016-12-19

Recalling FirmPhilips Electronics North America Corporation
Recall StatusTerminated
Product CodeLNH
Date Initiated2016-12-01
Date Terminated2017-08-31
Product Quantity9

Reason for Recall

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

Firm Action

Philips sent an Urgent Field Safety Notice Medical Device Correction letter dated November 2016 to all affected customers. The letter explains the issue and actions planned by Philips. There is no need for action to be taken by customer or user. Customers with questions should contact their local Philips representative Technical Support Line 1-800-722-9377.

Root Cause

Device Design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K110151ACHIEVA R4 1.5T AND ACHIEVA R4 3.0TPhilips Health Care · 2011-03-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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