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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Ingenia 1 .5T and Ingenia 3.OT MR systems

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 Class 2 Device Recall Philips Ingenia 1 .5T and Ingenia 3.OT MR systemssee related information
Date Initiated by FirmDecember 01, 2016
Date PostedDecember 19, 2016
Recall Status1 Terminated 3 on August 31, 2017
Recall NumberZ-0825-2017
Recall Event ID 75844
510(K)NumberK110151 
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
ProductIngenia 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
Code Information 781437: 15001, 15002, 15003 781438: 30001, 30002, 30003, 30004, 30005, 30006 
FEI Number 1218950
Recalling Firm/
Manufacturer		 Philips Electronics North America Corporation
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact
800-722-9377
Manufacturer Reason
for Recall		Possibility that a patient or user may be exposed to a very small level of touch current.
FDA Determined
Cause 2		Device Design
ActionPhilips 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 Commerce9
DistributionWorldwide Distribution -US including CA, NY and Internationally to United Kingdom, Australia, Norway, and Thailand
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = LNH
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