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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmMarch 01, 2005
Date PostedMarch 30, 2005
Recall Status1 Terminated 3 on July 18, 2005
Recall NumberZ-0661-05
Recall Event ID 31211
Product Classification Bed, Ac-Powered Adjustable Hospital - Product Code FNL
ProductHill-Rom TotalCare SpO2RT pulmonary therapy bed system, Model 1900.
Code Information All beds modified [to convert other beds to the TotalCare SpO2RT pulmonary therapy bed systems] with upgrade kits P1950A01 or P1950A02 between February 2002 and November 2004.
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		Siderails may stay up without latching into place.
FDA Determined
Cause 2		Other
ActionConsignees were notified via letter dated March 1, 2005 that Hill-Rom will contact them to coordinate a visit by Hill-Rom to upgrade affected beds.
Quantity in Commerce228 beds
DistributionNationwide 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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