Date Initiated by Firm |
April 08, 2008 |
Date Posted |
September 05, 2008 |
Recall Status1 |
Terminated 3 on October 13, 2010 |
Recall Number |
Z-1603-2008 |
Recall Event ID |
47469 |
Product Classification |
Bed, Ac-Powered Adjustable Hospital - Product Code FNL
|
Product |
Hill-Rom 100 Low Bed; Model No. P3930. |
Code Information |
All units. |
Recalling Firm/ Manufacturer |
Hill-Rom, Inc. 125 E Pearl St Batesville IN 47006
|
For Additional Information Contact |
800-445-3720
|
Manufacturer Reason for Recall |
The upper deck may collapse to its lowest position and the caster brakes may fracture if the bed is moved while the brakes are locked.
|
FDA Determined Cause 2 |
Device Design |
Action |
Consignees were notified via letter dated April 8, 2008 to lower these beds to their lowest position, to remove the beds from use if they move more than 1/2 inch with the brakes locked and that the firm will repair these beds when fixes become available.
If you have questions regarding this recall, contact Hill-Rom Technical Support at 800-445-3730. |
Quantity in Commerce |
753 beds |
Distribution |
Worldwide: USA and Canada. |
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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