Z-0825-2017Class II

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

Name: Z-0825-2017 Ingenia MR-OR; 781437, 781438 The MR-OR option is intended for allowing transfer of a neurosurgical patient...
Creator: Philips Electronics North America Corporation
Published: 2016-12-01
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2016-12-01 / Terminated / root cause: design

FDA source

Philips Electronics North America Corporation began a recall of 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... on 2016-12-01. FDA classified it as Class II and gives the reason as "Possibility that a patient or user may be exposed to a very small level of touch current". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0825-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-01
Posted: 2016-12-19
Terminated: 2017-08-31
Recalling firm: Philips North America LLC
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
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: Possibility that a patient or user may be exposed to a very small level of touch current.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 9
Distribution: Worldwide Distribution -US including CA, NY and Internationally to United Kingdom, Australia, Norway, and Thailand
Product codes and lots: 781437: 15001, 15002, 15003 781438: 30001, 30002, 30003, 30004, 30005, 30006

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0825-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0825-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19

Product code LNH

K110151Class IIAchieva R4 1.5T and Achieva R4 3.0TPhilips Health Care / cleared 2011-03-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)