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
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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/ Manufacturer |
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 | 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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