notyard
09-04-2008, 08:27 AM
FDA class II recall:
PRODUCT
a) Ambulift, standard basic model manually powered patient lift. The Ambulift is used
to move and lift patients from their beds, transport them to the bathroom, and lift
them in and out of the bath. Model AB1102 - Standard basic model Ambulift with
chair and leg rest. Model AB1552 - Standard basic model Ambulift with chair and
leg rest and scales, Recall # Z-1650-2008;
b) Ambulift Classic, battery powered patient lift. The Ambulift is used to move and
lift patients from their beds, transport them to the bathroom, and lift them in and
out of the bath. Model KDB1890-04US - Ambulift Classic with chair and leg rest.
Model KDB1895-04US - Ambulift Classic with chair, leg rest and scale, Recall #
Z-1651-2008
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arjo, Inc., Roselle, IL, by letters dated May 2, 2008.
Manufacturer: Arjo Med. AB, Gloucester, UK. Firm initiated recall is ongoing.
REASON
The armrests of the lift chair may push up, allowing the patient to slip down and out of the seat. The resultant fall could result in serious or fatal patient injuries.
VOLUME OF PRODUCT IN COMMERCE
14 units
DISTRIBUTION
Nationwide and Internationally
PRODUCT
a) Ambulift, standard basic model manually powered patient lift. The Ambulift is used
to move and lift patients from their beds, transport them to the bathroom, and lift
them in and out of the bath. Model AB1102 - Standard basic model Ambulift with
chair and leg rest. Model AB1552 - Standard basic model Ambulift with chair and
leg rest and scales, Recall # Z-1650-2008;
b) Ambulift Classic, battery powered patient lift. The Ambulift is used to move and
lift patients from their beds, transport them to the bathroom, and lift them in and
out of the bath. Model KDB1890-04US - Ambulift Classic with chair and leg rest.
Model KDB1895-04US - Ambulift Classic with chair, leg rest and scale, Recall #
Z-1651-2008
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arjo, Inc., Roselle, IL, by letters dated May 2, 2008.
Manufacturer: Arjo Med. AB, Gloucester, UK. Firm initiated recall is ongoing.
REASON
The armrests of the lift chair may push up, allowing the patient to slip down and out of the seat. The resultant fall could result in serious or fatal patient injuries.
VOLUME OF PRODUCT IN COMMERCE
14 units
DISTRIBUTION
Nationwide and Internationally