Skytron Infinity Series surgical light with dual lightheads, 5 bulbs in 1 - 22' lighthead and 8 bulbs in 1 - 30' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Model IF3022B. (note only the 22'' lighthead is affected.)
FDA Recall Z-0531-2007 · Posted 2007-02-22
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Recalling FirmSkytron, Div. The KMW Group, Inc
Recall StatusTerminated
Product CodeFTD
Date Initiated2007-01-08
Date Terminated2009-11-18
Product Quantity5,000 for all models.
Reason for Recall
If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide and Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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