Tri-Star Surgical Exam Light MR-16 ( Lamp Holder) used in the following: Model Numbers: TS2015W (wall mount) , TS2015M (
FDA device recall Z-1101-2007 · posted 2007-07-24 · Terminated
Recall details
- Recalling firm
- Sunnex Inc.
- Reason for recall
- Surgical and/or exam lamp holder may malfunction, discolor, melt and smolder.
- Action taken
- Sunnex notifiied distributors by letter March 9, 2007. Sunnex is providing replacement product to end users
- Root cause
- Other
- Status
- Terminated
- Product code
- FTA
- Quantity affected
- 30 lamps
- Distribution
- Nationwide
- Date initiated
- 2007-02-13
- Date posted
- 2007-07-24
- Date terminated
- 2009-01-06
- Location
- Natick, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRI*STAR (K930711) | Light Technology Systems | 1993-07-30 |