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U.S. Department of Health and Human Services

Class 2 Device Recall CosyCot

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 Class 2 Recall
CosyCot
see related information
Date Posted January 11, 2007
Recall Status1 Open
Recall Number Z-0485-2007
Recall Event ID 37003
Premarket Notification
510(K) Number
K970432 
Product Classification Warmer, Infant Radiant - Product Code FMT
Product Fisher & Paykel IW930 CosyCot Infant Radiant Warmer (with integrated bed) fitted with 9001W005J Elevator Module
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Recalling Firm/
Manufacturer
Fisher & Paykel Healthcare Ltd
15 Maurice Paykel Place
Auckland
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.
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 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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