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U.S. Department of Health and Human Services

Class 2 Device Recall HillRom

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 Class 2 Device Recall HillRomsee related information
Date Initiated by FirmApril 24, 2003
Date PostedMay 29, 2003
Recall Status1 Terminated 3 on September 25, 2003
Recall NumberZ-0903-03
Recall Event ID 25899
Product Classification Table, Obstetric (And Accessories) - Product Code KNC
ProductHill-Rom brand Century+ series bed
Code Information All units distributed between January 1, 1999 and July 1, 2002.
Recalling Firm/
Manufacturer
Hill-Rom, Inc.
125 E Pearl St
Batesville IN 47006
For Additional Information Contact
812-934-7777
Manufacturer Reason
for Recall
Possible electrical shock hazard, as the power cord grounding pin may break off or become detached.
FDA Determined
Cause 2
Other
ActionLetters dated April 24, 2003 were sent to each consignee instructing them to inspect the beds for power cords with non-flared ground pins, to cut plug off any such cords when found, and replace these plugs with new plugs with the flared ground pin. [The type of plug on the unit can be seen by the naked eye, as the plug is transparent plastic molding.]
DistributionUnited States, Bahamas, Bermuda, Canada, Colombia, Costa Rica, Dominican Republic, Guam, Japan, Mexico, Panama, Saudi Arabia, South Korea, Taiwan and Venezuela
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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