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U.S. Department of Health and Human Services

Class 2 Device Recall CosyCot

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  Class 2 Device Recall CosyCot see related information
Date Initiated by Firm October 09, 2006
Date Posted January 11, 2007
Recall Status1 Terminated 3 on April 26, 2012
Recall Number Z-0485-2007
Recall Event ID 37003
510(K)Number K970432  
Product Classification Infant Radiant Warmer - Product Code FMT
Product Fisher & Paykel IW930 CosyCot Infant Radiant Warmer (with integrated bed) fitted with 9001W005J Elevator Module
Code Information 9893JEU00110,  9993JEU00004,  9993JEU00018,  9993JEU00019,  9993JEU00021,  9993JEU00081,  9993JEU00082,  9993JEU00083,  9993JEU00084,  9993JEU00139,  9993JEU00140,  9993JEU00150,  9993JEU00151,  9993JEU00204,  9993JEU00205,  9993JEU00332,  9993JEU00333,  9993JEU00424,  9993JEU00448,  9993JEU00449,  9993JEU00450,  9993JEU00494,  9993JEU00536,  9993JEU00537,  9993JEU00605,  9993JEU00606,  9993JEU00662,  9993JEU00663,  9993JEU00669,  9993JEU00670,  0093JEU00064,  0093JEU00065,  0093JEU00066,  0093JEU00067,  0093JEU00076,  0093JEU00077,  0093JEU00078,  0093JEU00079,  0093JEU00086,  0093JEU00087,  0093JEU00088,  0093JEU00131,  0093JEU00132,  0093JEU00133,  0093JEU00134,  0093JEU00200,  0093JEU00266,  0093JEU00305,  0093JEU00306,  0093JEU00307,  0093JEU00308,  0093JEU00309,  0093JEU00310,  0093JEU00345,  0093JEU00346,  2000-93JEU00402,  2000-93JEU00436,  2000-93JEU00437,  2000-93JEU00438,  2000-93JEU00439,  2000-93JEU00499,  2000-93JEU00500,  2000-93JEU00505,  2000-93JEU00506,  2000-93JEU00507,  2000-93JEU00508,  2000-93JEU00541,  2000-93JEU00602,  2000-93JEU00603,  2000-93JEU00604,  2000-93JEU00605,  2000-93JEU00606,  2000-93JEU00607,  2000-93JEU00608,  2000-93JEU00609,  2000-93JEU00610,  2001-93JEU00048,  2001-93JEU00059,  2001-93JEU00060,  2001-93JEU00061,  2001-93JEU00062,  2001-93JEU00063,  2001-93JEU00064,  2001-93JEU00277,  2001-93JEU00293,  2001-93JEU00294,  2001-93JEU00295,  2001-93JEU00304,  2001-93JEU00305,  2001-93JEU00306,  2001-93JEU00403,  2001-93JEU00404,  2001-93JEU00405,  2001-93JEU00406,  2001-93JEU00407,  2001-93JEU00408,  2001-93JEU00409,  2001-93JEU00435,  2001-93JEU00436,  2001-93JEU00437,  2001-93JEU00438,  2001-93JEU00439,  2001-93JEU00440,  2001-93JEU00441,  2001-93JEU00442,  2001-93JEU00443,  2001-93JEU00444,  2001-93JEU00445,  2001-93JEU00446,  2001-93JEU00447,  2001-93JEU00448,  2001-93JEU00449,  2001-93JEU00450,  2001-93JEU00451,  2001-93JEU00452,  010827000538,  010907000568,  011002000604,  011002000605,  011002000606,  011019000663,  011019000664,  011019000665,  011019000666,  011106000715,  011106000716,  011115000743,  011115000744,  011115000745,  011115000746,  011116000747,  011116000748,  011116000749,  011116000750,  011119000751,  011119000752,  011217000830,  011217000831,  011217000832,  011217000833,  011217000834,  020130000101,  020130000102,  020130000103,  020218000186,  020218000187,  020218000188,  020218000189,  020218000190,  020221000204,  020221000205,  020221000206,  020221000207,  020221000208,  020226000217,  020226000218, 020403000292, 020405000317, 020405000318, 20405000319, 20405000320, 020405000321, 020405000322 , 020510000390, 020510000391, 020510000392 , 020510000393, 020510000394, 020523000410, 020523000411, 020523000412, 020523000413, 020606000420, 020611000432, 020611000433, 020611000434, 020611000435, 020611000436, 020611000437, 20611000438, 020611000439, 020611000440, 020611000441, 020611000442, 020611000443, 020612000444, 020801000544, 020801000545, 020802000546, 020802000547, 020802000548, 020802000549, 020802000550, 020802000551, 020904000736, 020911000676, 020912000682, 020913000689, 020916000699, 020916000700, 020917000701, 020917000702, 020917000703, 020917000704, 020917000705, 020917000706, 020917000707, 020917000708, 020918000709, 020918000710, 020924000732, 020924000733, 020924000734, 020924000735, 021004000751, 021008000758, 021008000759, 021105000876, 021105000879, 021105000880, 021107000890, 021107000891, 021112000910, 021112000911, 021112000912, 030113000041, 030113000042, 030113000043, 030113000044, 030113000045, 030117000074, 030117000075, 030117000076, 030117000077, 030120000078, 030120000079, 030120000080, 030120000081, 030305000241, 030307000245, 030307000246, 030307000247, 030307000248, 030307000249, 030307000250, 030307000251, 030307000252, 030313000253, 030313000254, 030313000255, 030408000300, 030408000301, 030408000302, 030505000356, 030505000357, 030512000384, 030512000385, 030512000386, 030512000387, 030512000388, 030512000389, 030512000390, 030616000477, 030616000478, 030618000494, 030618000495, 030618000496, 030618000497, 030618000498, 030618000499, 030618000500, 030618000501, 030708000558, 030708000559, 30708000560, 30708000560, 030711000580, 030711000581, 030711000582, 030711000583, 030717000599, 030722000611, 030802000635, 030802000636, 030804000637, 030812000662, 030905000702, 030905000703, 030905000704, 030912000718, 030922000747, 031003000780, 031003000781, 031015000814, 031015000815, 031015000816, 031015000817, 031021000841, 031021000842, 031021000843, 031021000844, 031028000862, 031028000863, 031104000876, 031106000891, 031106000892, 031120000964, 031125001001, 031125001002, 031125001003, 031125001004, 031125001005, 031217001112, 040112000001, 040112000002, 040112000003, 040112000004, 040112000006, 040112000007, 040112000008, 040112000009, 040112000010, 040112000011, 040119000023, 040119000024, 040120000030, 040120000031, 040204000112, 040204000113 & 040204000114
Recalling Firm/
Manufacturer		 Fisher & Paykel Healthcare Ltd
15 Maurice Paykel Place
Auckland New Zealand
Manufacturer Reason
for Recall		 This firm has received Product Complaint Reports concerning bending of the pivot plate. The elevator base of the CosyCot Infant Warmer incorporates a pivot plate which forms part of the mechanism allowing the CosyCot to raise and lower in height. A bent pivot plate generally results in the Warmer being unable to elevate properly. Other component failures may result.
FDA Determined
Cause 2		 Other
Action Fisher & Paykel Healthcare commenced sending out Product Correction Notifications letter via U.S. Postal Service certified mail October 9, 2006. This Product Correction Notice explained the nature of the problem and include a reminder of the maximum recommended weight of accessories. Two FAX Response Forms were provided, Part A for initial receipt of the Product Correction Notice and Part B for confirmation of the completed upgrade.
Quantity in Commerce 273 units in US & 9 in Canada
Distribution Nationwide and Canada
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 = FMT and Original Applicant = FISHER & PAYKEL ELECTRONICS LTD.
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