Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0748-03

TriaDyne I and TriaDyne II Powered Adjustable Hospital Beds

KCI USA, Inc. / initiated 2000-04-11 / Terminated

Kinetic Concepts, Inc began a recall of TriaDyne I and TriaDyne II Powered Adjustable Hospital Beds on . The reason FDA records is "Battery Failure/ Outgassing". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0748-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
KCI USA, Inc.
Product
TriaDyne I and TriaDyne II Powered Adjustable Hospital Beds
Product code
IOQ Bed, Flotation Therapy, Powered
Reason for recall
Battery Failure/ Outgassing
FDA root cause
Other
Action
Service centers were notified of the new battery maintenance policy on 4/11/2000 in a Technical Bulletin and again on 9/11/2000. Non-service center customers were notified by letter in October 2002.
Quantity in commerce
915 units
Distribution
Nationwide
Product codes and lots
All Serial Numbers