Skytron Infinity Series surgical light, 4 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF54, IF54EL, IF54LH and IF54S.
This recall has been terminated (originally issued February 22, 2007).
- Company
- Skytron, Div. The Kmw Group, Inc
- Recall Initiated
- January 8, 2007
- Posted
- February 22, 2007
- Terminated
- November 18, 2009
- Recall Number
- Z-0526-2007
- Quantity
- 5,000 for all models.
- Firm Location
- Grand Rapids, MI
- Official Source
- View on FDA website ↗
Reason for Recall
If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
Distribution
Nationwide and Canada.
Lot / Code Info
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).
Root Cause
Other
Action Taken
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.