FDAClass IIDecember 28, 2016

Ingenia MR-OR recall

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…

Why was Ingenia MR-OR recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

781437: 15001, 15002, 15003 781438: 30001, 30002, 30003, 30004, 30005, 30006

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…
Recalling firm
Philips Electronics North America Corporation
Quantity
9
Distribution
Worldwide Distribution -US including CA, NY and Internationally to United Kingdom, Australia, Norway, and Thailand
Recall date
December 28, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls