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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm December 05, 2003
Date Posted December 18, 2003
Recall Status1 Terminated 3 on November 23, 2005
Recall Number Z-0241-04
Recall Event ID 27875
Product Classification Unit, Neonatal Phototherapy - Product Code LBI
Product Phototherapy Lamp, Model 9001W501JE
Code Information The potentially affected lamps have serial numbers within the following ranges:  2000 SN 00501XXxxxxx SN 501XXxxxxx SN 2000-501XXxxxxx  2001 SN 2001-501XXxxxxx SN 01-xx xx xxxxxx  2002 SN 02 xx xx xxxxxx  2003 SN 03 xx xx xxxxxx
Recalling Firm/
Manufacturer		 Fisher & Paykel Healthcare Inc
22982 Alcalde Drive 101
Laguna Hills CA 92653
For Additional Information Contact Richard Cookson
949-470-3900 Ext. 327
Manufacturer Reason
for Recall		 Component placement presents risk of electrocution to patients.
FDA Determined
Cause 2		 Other
Action A recall letter and a set of instructions for fixing the units was sent to customers with instructions to complete a fax back form to indicate completion of the repair.
Quantity in Commerce 88
Distribution Nationwide.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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