Events

Recall of CosyCot

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Fisher & Paykel Healthcare Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    37003
  • Event Risk Class
    Class 2
  • Event Number
    Z-0485-2007
  • Event Initiated Date
    2006-10-09
  • Event Date Posted
    2007-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49741
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Infant Radiant Warmer - Product Code FMT
  • 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.
  • 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.

Device

CosyCot
  • Model / Serial
    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 Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada
  • Product Description
    Fisher & Paykel IW930 CosyCot Infant Radiant Warmer (with integrated bed) fitted with 9001W005J Elevator Module
  • Manufacturer
    Fisher & Paykel Healthcare Ltd

Manufacturer

Fisher & Paykel Healthcare Ltd
  • Manufacturer Address
    Fisher & Paykel Healthcare Ltd, 15 Maurice Paykel Place, Auckland New Zealand
  • Source
    USFDA