Recall Z-1231-2008 ยท MPH
Chattanooga Corp Inc
INTELECT MOBILE COMBO, Model No. 2778, Chattanooga Group, Hixson, TN 37343, Made in the USA, Not for sale in the U.S.A.
| Date | Jun 25, 2008 (initiated Dec 17, 2007) |
| Status | Terminated |
| Reason | Device malfunction: causing electric shock and burn. |
| 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 | 2541 units |
| Distribution | Worldwide Distribution - including USA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031077 | VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM Chattanooga Group, Dec 11, 2003 |