Medical Device Recalls - Hill-Rom 70 Semi-Electric Bed (Class 2 Recall)
MedSun: Newsletter #34, March 2009
Recall posted on FDA website
Date Recall Initiated November 11, 2008
Date Posted January 16, 2009
Recall Number Z-0506-2009
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.
Code Information Serial numbers HC100001 through HC101261.
Recalling Firm/Manufacturer
Hill-Rom, Inc.
125 E Pearl St
Batesville , Indiana 47006
For Addition Information Contact
Steven S. Hollingsworth
812-934-6727
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.
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.
Additional Information:
Hill-Rom 70 Semi-Electric Bed Recall. FDA Recall. November 11, 2008.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?ID=74910