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U.S. Department of Health and Human Services

Class 2 Device Recall Edge 1.5T MRI

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  Class 2 Device Recall Edge 1.5T MRI see related information
Date Initiated by Firm September 19, 2008
Date Posted September 17, 2010
Recall Status1 Terminated 3 on September 17, 2010
Recall Number Z-2429-2010
Recall Event ID 49489
510(K)Number K931544  K964626  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product Edge Nuclear Magnetic Resonance Imaging System. "1.5T Edge High-Field Magnetic Resonance Imaging System, Picker International, Inc. World Headquarters 595 Miner Road Cleveland, Ohio 44143, U.S.A.".
Code Information 28 units are identified as Site Numbers: 200300, 200320, 200692, 200717, 200896, 200922, 200997, 201507, 202500, 202610, 203528, 204199, 207459, 218110, 41127, 500322, 500326, 500327, 505573, 73004, 73440, 75163, 75724, 76855, 78528, 78544, 78842 and 79543.
Recalling Firm/
Manufacturer		 Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell WA 98021-8431
For Additional Information Contact Philips Call Center
800-722-9377
Manufacturer Reason
for Recall		 Water may collect and freeze in the vent pipe. This can rupture the magnet vessel during a cryogen transfer, and release helium into the MRI suite.
FDA Determined
Cause 2		 Other
Action Philips issued an Urgent Correction letter dated 09/19/2008 to their consignees, identifying the reason for the recall and the affected products. The firm issued the Field Change Order (FCO) 78100232. Field service engineers will visit each consignee and conduct an inspection of the magnets venting system of Edge, Vista, Eclipse, Polaris, Infinion, and Panorama 0.6T MRI systems. The consignees should contact the Philips Call Center at 1-800-772-9377, #5 #2 and reference "FCO 78100232".
Quantity in Commerce 28 units
Distribution Nationwide Distribution: USA., including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY. There is no distribution to foreign consignees.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = LNH and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
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