Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0873-2007

Light Source 300 Watt Xenon Lamp used in the following models: Viking EndoSite Xenon, Model 8050-1 and Boston...

ConMed Corporation / initiated 2007-04-05 / Terminated / root cause: manufacturing process

Vision Systems Group, A Div of Viking Systems began a recall of Light Source 300 Watt Xenon Lamp used in the following models: Viking EndoSite Xenon, Model 8050-1 and Boston Scientific Spyglass 300W Light Source (M00546190) on . The reason FDA records is "Incorrect power entry module assembled into unit may cause burning to insulation, compromised electrical emissions and premature light source failure". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0873-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
ConMed Corporation
Product
Light Source 300 Watt Xenon Lamp used in the following models: Viking EndoSite Xenon, Model 8050-1 and Boston Scientific Spyglass 300W Light Source (M00546190)
Product code
KOG
Reason for recall
Incorrect power entry module assembled into unit may cause burning to insulation, compromised electrical emissions and premature light source failure
Root cause tag
manufacturing process
FDA root cause
Nonconforming Material/Component
Action
Viking notified 2 distributors and 1 end user by telephone on 3/15/07. Viking representatives performed on site visit to perform inspection and replace units if needed.
Quantity in commerce
4
Distribution
Nationwide to CA and NC
Product codes and lots
Units manufactured from 1/23/07 through 3/14/07 with serial numbers: 120906, 016707, 016907, 017007