—#151445

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

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K110151
Affected lot / code info: 781437: 15001, 15002, 15003 781438: 30001, 30002, 30003, 30004, 30005, 30006

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Philips Electronics North America Corporation
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

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

Timeline

Recall initiated: 2016-12-01
Posted by FDA: 2016-12-19
Terminated: 2017-08-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #151445. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.