Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1100-2007

Sunnex Celestial Star MR-16 (lamp holder) Medical Examination Lighting used in Model Numbers: CS2050C...

Sunnex, Inc. / initiated 2007-02-13 / Terminated

Sunnex Inc. began a recall of Sunnex Celestial Star MR-16 (lamp holder) Medical Examination Lighting used in Model Numbers: CS2050C (ceiling mount), CS2050W (wall mount). CS2050D (dual... on . The reason FDA records is "Surgical and/or exam lamp holder may malfunction, discolor, melt and smolder". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1100-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Sunnex, Inc.
Product
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).
Product code
FTA Light, Surgical, Accessories
Reason for recall
Surgical and/or exam lamp holder may malfunction, discolor, melt and smolder.
FDA root cause
Other
Action
Sunnex notifiied distributors by letter March 9, 2007. Sunnex is providing replacement product to end users
Quantity in commerce
346 lamps
Distribution
Nationwide
Product codes and lots
Units manufactured between May 15, 2006 through October 1, 2006