Recall Z-1101-2007 ยท FTA Light, Surgical, Accessories
Sunnex Inc.
Tri-Star Surgical Exam Light MR-16 ( Lamp Holder) used in the following: Model Numbers: TS2015W (wall mount) , TS2015M (mobile) , TS2015W (wall mount) , TS2035M (mobile)
| Date | Jul 24, 2007 (initiated Feb 13, 2007) |
| Status | Terminated |
| Reason | Surgical and/or exam lamp holder may malfunction, discolor, melt and smolder. |
| Root cause | Other |
| Action | Sunnex notifiied distributors by letter March 9, 2007. Sunnex is providing replacement product to end users |
| Quantity | 30 lamps |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K930711 | TRI*STAR Light Technology Systems, Jul 30, 1993 |