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U.S. Department of Health and Human Services

Class 2 Device Recall Century

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 Class 2 Device Recall Centurysee related information
Date Initiated by FirmMay 20, 2005
Date PostedJune 30, 2005
Recall Status1 Terminated 3 on August 12, 2005
Recall NumberZ-0948-05
Recall Event ID 32108
Product Classification Bed, Ac-Powered Adjustable Hospital - Product Code FNL
ProductHill-Rom Century+ Bed, Model P1400.
Code Information Beds built between March 2005 and May 2005.
FEI Number 1824206
Recalling Firm/
Manufacturer
Hill-Rom, Inc.
125 E Pearl St
Batesville IN 47006
For Additional Information Contact
800-445-3720
Manufacturer Reason
for Recall
Sleep bed pivot bolts may break, allowing the head section to shift or to drop to one side.
FDA Determined
Cause 2
Other
ActionConsignees were notified via letter dated 5/20/05 that the firm will visit consignees to make corrections to the beds.
Quantity in Commerce218
DistributionNationwide (California, District of Columbia, Florida, Massachusetts, Montana, Nevada, New Jersey, New York, Pennsylvania, Texas, Virginia), Brazil and Canada.
Total Product Life CycleTPLC Device Report

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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