| Class 2 Device Recall Skytron Infinity Series surgical light | |
Date Initiated by Firm | January 08, 2007 |
Date Posted | February 22, 2007 |
Recall Status1 |
Terminated 3 on November 18, 2009 |
Recall Number | Z-0528-2007 |
Recall Event ID |
37120 |
510(K)Number | K915285 |
Product Classification |
surgical light - Product Code FTD
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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 MI 49512-2008
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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 | 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
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