FDA Medical Device Recalls (openFDA)
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)
- Recall number
- Z-1101-2007
- Recalling firm
- Sunnex Inc.
- Product
- 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)
- Status
- Terminated
- Initiated
- 2007-02-13
- Posted
- 2007-07-24
- Terminated
- 2009-01-06
- 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
- Lot, serial or model codes
- Units manufactured between May 15, 2006 through October 1, 2006
- 510(k) numbers
- ["K930711"]
- PMA numbers
- not on file
- Product code
- FTA
- Firm FEI
- 1000583780
- Firm city
- Natick
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28