Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0506-2009

Hill-Rom 70 Semi-Electric Bed, Hill-Rom Company, Batesville, IN.; Model HS-968. The bed is a general purpose...

Hill-Rom Inc. / initiated 2008-11-11 / Terminated

Hill-Rom, Inc. began a recall of Hill-Rom 70 Semi-Electric Bed, Hill-Rom Company, Batesville, IN.; Model HS-968. The bed is a general purpose bed for use with low to medium acuity patients in... on . The reason FDA records is "Failure, mechanical: If the bed mechanism is cranked downward when the bed is already in its lowest position, the springs may cause the bed to rise suddenly if the bed is empty, more slowly if occupied by a patient, or...". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0506-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Hill-Rom Inc.
Product
Hill-Rom 70 Semi-Electric Bed, Hill-Rom Company, Batesville, IN.; Model HS-968. The bed is a general purpose bed for use with low to medium acuity patients in the home care environment.
Product code
FNL Bed, Ac-Powered Adjustable Hospital
Reason for recall
Failure, mechanical: If the bed mechanism is cranked downward when the bed is already in its lowest position, the springs may cause the bed to rise suddenly if the bed is empty, more slowly if occupied by a patient, or when the patient exits the bed. For further information, please contact Hill-Rom, Inc. at 800-445-3720.
FDA root cause
Other
Action
Consignees were notified of the problem by letter dated 11/11/08 and instructed to position the bed at least 3 inches above the lowest bed position in order to prevent the problem, and then to only use the pendant electronic controls to raise and lower the head and foot sections of the bed, until Hill-Rom can repair the bed. The letter was entitled "Urgent Medical Device Correction."
Quantity in commerce
567
Distribution
Nationwide.
Product codes and lots
Serial numbers HC100001 through HC101261.