510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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Z-2431-2010

Eclipse, Nuclear Magnetic Resonance Imaging system, Magnet Subsystem, Picker International, Inc. World...

Philips North America LLC / initiated 2008-09-19 / Terminated
FDA source (opens on fda.gov)

Philips Medical Systems North America Co. Phillips began a recall of Eclipse, Nuclear Magnetic Resonance Imaging system, Magnet Subsystem, Picker International, Inc. World Headquarters 595 Miner Road Cleveland, Ohio 44143... on . The reason FDA records is "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". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-2431-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Philips North America LLC
Product
Eclipse, Nuclear Magnetic Resonance Imaging system, Magnet Subsystem, Picker International, Inc. World Headquarters 595 Miner Road Cleveland, Ohio 44143, U.S.A.".
Product code
LNH System, Nuclear Magnetic Resonance Imaging
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 root cause
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
141 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.
Product codes and lots
141 units are identified as Site Numbers:  205580, 214178, 204898, 215014, 238042, 223106, 204913, 218202, 546102, 204320, 203515, 205771, 223029, 220012, 238223, 217489, 238200, 209637, 205582, 205773, 238151, 547644, 205699, 204140, 549386, 223236, 550477, 204128, 74269, 238135, 238087, 209689, 238082, 238198, 223003, 209535, 218105, 220033, 204912, 209721, 238019, 205720, 42635610, 223036, 205772, 238093, 238055, 209874, 218077, 220039, 223303, 218218, 212824, 225131, 209288, 238224, 212802, 238096, 215016, 223030, 238043, 209666, 238023, 238013, 203583, 209555, 218203, 218122, 218123, 209536, 203514, 218073, 214398, 204934, 209571, 238209, 212816, 223341, 209572, 218035, 203034, 205700, 203069, 223019, 238010, 548641, 220031, 205577, 223921, 238214, 204318, 209538, 225019, 238086, 540928, 220013, 203510, 203511, 204933, 238014, 218107, 209660, 212863, 218104, 223144, 225073, 218078, 203127, 223146, 207460, 205774, 203036, 238015, 245524, 212943, 214511, 205557, 223021, 204162, 204907, 217494, 238027, 542738, 205554, 220026, 220014, 223027, 225188, 238092, 238227, 238165, 209684, 238046, 223024, 238091, 223737, 220001, 223039, 204917, 204930, and 223237.