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U.S. Department of Health and Human Services

Class 2 Device Recall Skytron Infinity series (also called Astro series) minor surgery light

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  Class 2 Device Recall Skytron Infinity series (also called Astro series) minor surgery light see related information
Date Initiated by Firm January 08, 2007
Date Posted February 22, 2007
Recall Status1 Terminated 3 on November 18, 2009
Recall Number Z-0524-2007
Recall Event ID 37120
510(K)Number K915285  
Product Classification surgical light - Product Code FTD
Product Skytron Infinity series (also called Astro series) minor surgery light, 3 bulbs in 1 - 19' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Japan; Models IN19, IN19EL, IN19LH and IN19S.
Code Information Each lighthead bears a unique serial number. For units with model numbers beginning with IN 19, all seven digit serial numbers with the following numbers in the third and fourth positions of the numerical series: 95, 96, 97, 98 or 99 (example: xx95xxx) plus all eight serial numbers with a 0 in the fifth position (example: xxxx0xxx).
Recalling Firm/
Skytron, Div. The KMW Group, Inc
5000 36th St Se
Grand Rapids MI 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
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 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.
510(K) Database 510(K)s with Product Code = FTD and Original Applicant = SKYTRON, DIV. THE KMW GROUP, INC.