Fisher & Paykel IW930 CosyCot Infant Radiant Warmer (with integrated bed) fitted with 9001W005J Elevator Module
FDA device recall Z-0485-2007 · posted 2007-01-11 · Terminated
Recall details
- Recalling firm
- Fisher & Paykel Healthcare Ltd
- 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 taken
- 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
- Status
- Terminated
- Product code
- FMT
- Quantity affected
- 273 units in US & 9 in Canada
- Distribution
- Nationwide and Canada
- Date initiated
- 2006-10-09
- Date posted
- 2007-01-11
- Date terminated
- 2012-04-26
- Location
- Auckland, New Zealand
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INFANT RADIANT WARMER - MODELS IW910 AND IW920 (K970432) | Fisher & Paykel Electronics , Ltd. | 1997-05-07 |