Recall Z-0531-2007 ยท FTD Lamp, Surgical
Skytron, Div. The KMW Group, Inc
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.)
| Date | Feb 22, 2007 (initiated Jan 8, 2007) |
| Status | Terminated |
| Reason | If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount. |
| Root cause | 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 | 5,000 for all models. |
| Distribution | Nationwide and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K915285 | SKYTRON INFINITY SERIES SURGICAL LIGHTS Skytron, Div. the Kmw Group, Inc., Feb 20, 1992 |