Reported Dec 28, 2016 · Terminated

Ingenia MR-OR; 781437, 781438 The MR-OR option is intended for allowing transfer of a neurosurgical patient from OR…

Philips Electronics North America Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips Electronics North America Corporation · 3000 Minuteman Rd · Andover, MA · 01810-1032

Is this the product you have?

  • 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
Lot codes and dates
    • 781437: 15001
    • 15002
    • 15003 781438: 30001
    • 30002
    • 30003
    • 30004
    • 30005
    • 30006
Amount recalled
9

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 31, 2017 · Data as of Sep 19, 6:12 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.