Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0671-05

Micro-temp II heat therapy unit, model #747

Gentherm Medical, LLC / initiated 2005-01-18 / Terminated

Cincinnati Sub-Zero Products Inc began a recall of Micro-temp II heat therapy unit, model #747 on . The reason FDA records is "There is the potential that the power switch assembly can dislodge from the cabinet during use". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0671-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Gentherm Medical, LLC
Product
Micro-temp II heat therapy unit, model #747.
Product code
ILO Pack, Hot Or Cold, Water Circulating
Reason for recall
There is the potential that the power switch assembly can dislodge from the cabinet during use.
FDA root cause
Other
Action
The recalling firm sent letters, dated 1/18/04.
Quantity in commerce
553 devices.
Distribution
The product was distributed to hospitals throughout the United States.
Product codes and lots
All units containing version 0.70 software.