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Terminated

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)

FDA Recall Z-1101-2007 · Posted 2007-07-24

Recalling FirmSunnex Inc.
Recall StatusTerminated
Product CodeFTA
Date Initiated2007-02-13
Date Terminated2009-01-06
Product Quantity30 lamps

Reason for Recall

Surgical and/or exam lamp holder may malfunction, discolor, melt and smolder.

Firm Action

Sunnex notifiied distributors by letter March 9, 2007. Sunnex is providing replacement product to end users

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K930711TRI*STARLight Technology Systems · 1993-07-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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