FDA Recall
Terminated
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.
Recall: Z-0530-2007
·
Initiated January 8, 2007
Recall
- Recall Number
- Z-0530-2007
- Event Number
- 37120
- Firm
- Skytron, Div. The KMW Group, Inc
- FEI Number
- 1825014
- Product Code
- FTD
- Status
- Terminated
- Root Cause
- Other
- Initiated
- January 8, 2007
- Posted
- February 22, 2007
- Terminated
- November 18, 2009
- Address
- 5000 36th St Se, Grand Rapids, MI, 49512-2008
Description
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.
Reason
If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
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.
Distribution
Nationwide and Canada.
Quantity
5,000 for all models.