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U.S. Department of Health and Human Services

Class 2 Device Recall Ingenia 1.5T and 3.0T MRI Systems

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 Class 2 Recall
Ingenia 1.5T and 3.0T MRI Systems
see related information
Date Posted November 28, 2011
Recall Status1 Terminated on February 22, 2013
Recall Number Z-0293-2012
Recall Event ID 60304
Premarket Notification
510(K) Number
K110151 
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product Ingenia 1.5T and 3.0T MRI Systems, Model Numbers: 781396 and 781377, 510(k) #K110151. System units equipped with software version: 4.1.1 are subject to recall/field correction. This MRI system is indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities. Image appearance is determined by the spatial distribution and flow as well as by many different NMR related properties of the tissue and anatomy studied and the MRI scan technique applied. These images and/or spectra, when interpreted by a trained physician, provide information that may assist the diagnosis.
Code Information Twelve (12) units were distributed to customers in the U.S. The recalled Serial Numbers are: 42001, 42003, 41000, 41005, 42006, 42040, 41035, 41028, 42034, 42033, 41034 and 42038.
Recalling Firm/
Manufacturer
Philips Medical Systems (Cleveland) Inc
595 Miner Road
Cleveland, Ohio 44143-2131
For Additional Information Contact Mike McAndrew
440-483-7000
Manufacturer Reason
for Recall
The firm determined that during scanning procedures, for some larger patients, some reddening of the skin of can occur in certain instances due to RF heating when the torso of the patient is positioned within the body coil.
FDA Determined
Cause 2
DESIGN: Software Design
Action Philips Medical Systems ( Cleveland) Inc. sent a Urgent Field Safety Notice dated August 3, 2011, to all affected customers. Philips Field Service Engineers were dispatched to the affected customer sites to deliver the recall notification and to perform the necessary software corrections. The letter lists the affected MRI systems; describes the problem; the actions to be taken by the customer/user; it also informs the customer of the upcoming software correction which will be applied to each unit by the Philips Field Service Engineers in order to address this issue. If any additional information is required, the customer is instructed to contact their local Philips Field Service Engineer. For further questions please call (440) 483-7000.
Quantity in Commerce 26 units - 12 units distributed in U.S. & 16 distributed to foreign customers
Distribution Worldwide Distribution -- USA (nationwide) including the states of AL, AZ, CA, GA, OR, MI, NJ and TX., and the countries of AU, BE, CH, DE, FR, JP, NL and SE.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = PHILIPS HEALTHCARE
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