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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Skytron Infinity Series surgical light		see related information
Date Posted February 22, 2007
Recall Number Z-0528-2007
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
Reason for
Recall		 If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
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.
 
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