FDA Recall
Terminated
Skytron Infinity Series (also called Astro series) minor surgery light with dual lightheads, 3 bulbs in each of 2 - 19' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IN1919 and IN1919EL and IN1919EL/PT.
Recall: Z-0525-2007
·
Initiated January 8, 2007
Recall
- Recall Number
- Z-0525-2007
- 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 (also called Astro series) minor surgery light with dual lightheads, 3 bulbs in each of 2 - 19' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IN1919 and IN1919EL and IN1919EL/PT.
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.