Recall Z-1100-2007 ยท FTA Light, Surgical, Accessories
Sunnex Inc.
Sunnex Celestial Star MR-16 (lamp holder) Medical Examination Lighting used in Model Numbers: CS2050C (ceiling mount), CS2050W (wall mount). CS2050D (dual mount) , CS2050M (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 | 346 lamps |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.