Z-0485-2007

Fisher & Paykel IW930 CosyCot Infant Radiant Warmer (with integrated bed) fitted with 9001W005J Elevator...

Name: Z-0485-2007 Fisher & Paykel IW930 CosyCot Infant Radiant Warmer (with integrated bed) fitted with 9001W005J Elevator...
Creator: Fisher & Paykel Healthcare Ltd
Published: 2006-10-09
License: https://open.fda.gov/license/

Fisher & Paykel Healthcare, Inc. / initiated 2006-10-09 / Terminated

FDA source

Fisher & Paykel Healthcare Ltd began a recall of Fisher & Paykel IW930 CosyCot Infant Radiant Warmer (with integrated bed) fitted with 9001W005J Elevator Module on 2006-10-09. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0485-2007
Status: Terminated
Initiated: 2006-10-09
Posted: 2007-01-11
Terminated: 2012-04-26
Recalling firm: Fisher & Paykel Healthcare, Inc.
Product: Fisher & Paykel IW930 CosyCot Infant Radiant Warmer (with integrated bed) fitted with 9001W005J Elevator Module
Product code: FMT Warmer, Infant Radiant
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 root cause: 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
Product codes and lots: 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

Product code FMT

K970432Class IIInfant Radiant Warmer - Models Iw910 and Iw920Fisher & Paykel Electronics , Ltd. / cleared 1997-05-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)