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U.S. Department of Health and Human Services

Class 2 Device Recall Skytron Infinity Series surgical light

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 Class 2 Recall
Skytron Infinity Series surgical light
see related information
Date Posted February 22, 2007
Recall Status1 Terminated on November 18, 2009
Recall Number Z-0528-2007
Recall Event ID 37120
Premarket Notification
510(K) Number
K915285 
Product Classification Lamp, Surgical - Product Code FTD
Product Skytron Infinity Series surgical light with triple lightheads, 4 bulbs in each of 3 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF545454 and IF545454EL.
Code Information Each lighthead bears a unique serial number. For units with model numbers beginning in IF54, all serial numbers with the following numbers in the third and fourth positions of the numerical series: 95, 96, 97, 98, 99, 00 or 01 (example: xx98xxx).
Recalling Firm/
Manufacturer
Skytron, Div. The KMW Group, Inc
5000 36th St Se
Grand Rapids, Michigan 49512-2008
For Additional Information Contact Mary Preston-Murphy
800-759-8766 Ext. 3048
Manufacturer Reason
for Recall
If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
FDA Determined
Cause 2
DESIGN: Device Design
Action The firm initially notified consignees of this problem on 11/23/1999 and again on 11/01/2002 and most lights have already been corrected. Remaining consignees with lights in need of correction were notified of the problem via letter dated 1/8/07 and instructed to contact the distributor to have their lights inspected and modified.
Quantity in Commerce 5,000 for all models.
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
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FTD and Original Applicant = SKYTRON, DIV. THE KMW GROUP, INC.
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