Date Initiated by Firm |
November 11, 2008 |
Date Posted |
January 16, 2009 |
Recall Status1 |
Terminated 3 on December 31, 2009 |
Recall Number |
Z-0506-2009 |
Recall Event ID |
50181 |
Product Classification |
AC-Powered Adjustable Hospital Bed - Product Code FNL
|
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 IN 47006
|
For Additional Information Contact |
Steven S. Hollingsworth 812-934-6727
|
Manufacturer 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 Determined Cause 2 |
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. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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