Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1227-2008

INTELECT ADVANCED, Model No. 2762CC, Chattanooga Group, Hixson, TN 37343, Made in the USA, Not for sale in...

Chattanooga Corp Inc / initiated 2007-12-17 / Terminated / root cause: design

Chattanooga Corp Inc began a recall of INTELECT ADVANCED, Model No. 2762CC, Chattanooga Group, Hixson, TN 37343, Made in the USA, Not for sale in the U.S.A on . The reason FDA records is "Device malfunction: causing electric shock and burn". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1227-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Chattanooga Corp Inc
Product
INTELECT ADVANCED, Model No. 2762CC, Chattanooga Group, Hixson, TN 37343, Made in the USA, Not for sale in the U.S.A.
Product code
MPH
Reason for recall
Device malfunction: causing electric shock and burn.
Root cause tag
design
FDA root cause
Device Design
Action
Beginning on 12/17/2007, Chattanooga Corp. sent two recall notification letters, via UPS mail, to its consignees informing them of the situation. The letters stated that the recall was to the user level and requested that the user perform the software upgrade, which will eliminate the possibility of shock and burn.
Quantity in commerce
2993 units
Distribution
Worldwide Distribution - including USA
Product codes and lots
Serial numbers 1000 - 3993