FDA Medical Device Recalls (openFDA)
Fisher & Paykel Healthcare Ltd: Fisher & Paykel IW930 CosyCot Infant Radiant Warmer (with integrated bed) fitted with 9001W005J Elevator Module
- Recall number
- Z-0485-2007
- Recalling firm
- Fisher & Paykel Healthcare Ltd
- Product
- Fisher & Paykel IW930 CosyCot Infant Radiant Warmer (with integrated bed) fitted with 9001W005J Elevator Module
- Status
- Terminated
- Initiated
- 2006-10-09
- Posted
- 2007-01-11
- Terminated
- 2012-04-26
- Reason
- 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.
- 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
- 273 units in US & 9 in Canada
- Distribution
- Nationwide and Canada
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K970432"]
- PMA numbers
- not on file
- Product code
- FMT
- Firm FEI
- 3002806988
- Firm city
- Auckland
- Firm state
- not on file
- Firm country
- New Zealand
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28