Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0583-05

KinAir MedSurg, flotation therapy, powered hospital bed, manufactured by Kinetic Concepts, Inc., San Antonio...

KCI USA, Inc. / initiated 2003-06-06 / Terminated / root cause: manufacturing process

Kinetic Concepts, Inc began a recall of KinAir MedSurg, flotation therapy, powered hospital bed, manufactured by Kinetic Concepts, Inc., San Antonio, Texas on . The reason FDA records is "Weld failure causes side rail welds to turn upside down or break off of the bed". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0583-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
KCI USA, Inc.
Product
KinAir MedSurg, flotation therapy, powered hospital bed, manufactured by Kinetic Concepts, Inc., San Antonio, Texas
Product code
IOQ Bed, Flotation Therapy, Powered
Reason for recall
Weld failure causes side rail welds to turn upside down or break off of the bed.
Root cause tag
manufacturing process
FDA root cause
Other
Action
The firm initiated the recall by telephone on 06/06/2003. The firm has inspected and corrected the beds.
Quantity in commerce
1181 beds
Distribution
The beds were distributed nationwide and to Brazil.
Product codes and lots
Serial Numbers KASK00001 through KASK01212