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Class 2 Device Recall Skytron Infinity Series surgical light |
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Date Initiated by Firm |
January 08, 2007 |
Date Posted |
February 22, 2007 |
Recall Status1 |
Terminated 3 on November 18, 2009 |
Recall Number |
Z-0530-2007 |
Recall Event ID |
37120 |
510(K)Number |
K915285
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Product Classification |
surgical light - Product Code FTD
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Product |
Skytron Infinity Series surgical light with dual lightheads, 5 bulbs in each of 2 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF2222, IF2222-B, IF2222B/PT, IF2222EL and IN2222EL. |
Code Information |
Each lighthead bears a unique serial number. For units with model numbers beginning with IF22, all serial numbers with the following numbers in the third and fourth position of the numerical series: 95, 96, 97, 98, 99 or 00 (examples: xx97xxxx or xx00xxxB). For units with model numbers beginning with IN22 , all serial numbers with the following numbers in the third and fourth positions of the numerical series: 92, 93 or 94 (example: xx93xxxx). |
Recalling Firm/ Manufacturer |
Skytron, Div. The KMW Group, Inc 5000 36th St Se Grand Rapids MI 49512-2008
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For Additional Information Contact |
Mary Preston-Murphy 800-759-8766 Ext. 3048
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Manufacturer Reason for Recall |
If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
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FDA Determined Cause 2 |
Other |
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
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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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510(K) Database |
510(K)s with Product Code = FTD and Original Applicant = SKYTRON, DIV. THE KMW GROUP, INC.
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