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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 Device Recall Skytron Infinity Series surgical lightsee related information
Date Initiated by FirmJanuary 08, 2007
Date PostedFebruary 22, 2007
Recall Status1 Terminated 3 on November 18, 2009
Recall NumberZ-0527-2007
Recall Event ID 37120
510(K)NumberK915285 
Product Classification surgical light - Product Code FTD
ProductSkytron Infinity Series surgical light with dual lightheads, 4 bulbs in each of 2 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF5454 and IF5454EL.
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 MI 49512-2008
For Additional Information ContactMary 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		Other
ActionThe 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 Commerce5,000 for all models.
DistributionNationwide and Canada.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FTD
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