Fisher & Paykel IW930 CosyCot Infant Radiant Warmer (with integrated bed) fitted with 9001W005J Elevator Module
FDA Recall Z-0485-2007 · Posted 2007-01-11
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Recalling FirmFisher & Paykel Healthcare Ltd
Recall StatusTerminated
Product CodeFMT
Date Initiated2006-10-09
Date Terminated2012-04-26
Product Quantity273 units in US & 9 in Canada
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide and Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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