Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0026-2007

ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed

Extended Care Air Therapy Systems Inc / initiated 2006-04-05 / Terminated

Extended Care Air Therapy Systems Inc began a recall of ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed on . The reason FDA records is "Component defect- Following assembly and distribution, two (2) bolts may bend in the bed frame, which may allow the bed to tip into the wall". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0026-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Extended Care Air Therapy Systems Inc
Product
ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed
Product code
FNL Bed, Ac-Powered Adjustable Hospital
Reason for recall
Component defect- Following assembly and distribution, two (2) bolts may bend in the bed frame, which may allow the bed to tip into the wall
FDA root cause
Other
Action
The firm sent a Product Advisory Letter to their distributor/customers on 4/5/2006. The letter instructs the distributors as to the correct way to handle the beds during movement, loading, and unloading onto delivery trucks. The letter also urges the distributors to inspect the bed frame units in inventory at their locations for the presence of any bending, or damage to the four frame bolts. The letter states that the company will replace the bolts as soon as possible when ever necessary.
Quantity in commerce
102 beds
Distribution
The recalled medical beds were distributed to six (6) wholesale/distributor customers located in the following states: KS, TN, MI, PA, and LA.
Product codes and lots
Serial Numbers: E9084 - E9094 & E10001 - E10099. The serial # is found at the bottom of the stick on label. The label is affixed to the foot of the bed frame on the right hand side.