Recall Z-0485-2007 ยท FMT Warmer, Infant Radiant
Fisher & Paykel Healthcare Ltd
Fisher & Paykel IW930 CosyCot Infant Radiant Warmer (with integrated bed) fitted with 9001W005J Elevator Module
| Date | Jan 11, 2007 (initiated Oct 9, 2006) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970432 | INFANT RADIANT WARMER - MODELS IW910 AND IW920 Fisher & Paykel Electronics , Ltd., May 7, 1997 |