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U.S. Department of Health and Human Services

Class 2 Device Recall HillRom Affinity 4 Birthing Bed; Model P3700B.

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  Class 2 Device Recall HillRom Affinity 4 Birthing Bed; Model P3700B. see related information
Date Initiated by Firm September 06, 2007
Date Posted April 02, 2008
Recall Status1 Terminated 3 on October 15, 2010
Recall Number Z-0617-2008
Recall Event ID 45444
510(K)Number K915779  
Product Classification Birthing Bed - Product Code HDD
Product Hill-Rom Affinity 4 Birthing Bed; Model P3700B, Hill-Rom, Inc., Batesville, IN 47006
Code Information All units manufactured prior to 11/20/07; all beds with serial numbers below 1232AA6856.
Recalling Firm/
Hill-Rom, Inc.
125 E Pearl St
Batesville IN 47006
For Additional Information Contact
Manufacturer Reason
for Recall
Brake failure: The brakes may not hold or lock properly.
FDA Determined
Cause 2
Component design/selection
Action Hill-Rom notified consignees via Urgent Medical Device Correction letter dated 9/6/07. The letter instructed facilities to continue using the beds if they pass a test of the brake mechanism; and a Hill-Rom representative will contact the facility to schedule a replacement of the detent mechanism and adjustment of the casters.
Quantity in Commerce 1,796
Distribution Worldwide Distribution - USA, Argentina, Australia, Bahamas, Belgium, Belize, Brazil, Canada, China, Denmark, Dominican Republic, France, Germany, Guam, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Jordan, Kenya, Malaysia, Mexico, Netherlands, Norway, Philippines, Russia, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Syria, Turkey, United Arab Emirates and United Kingdom.
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = HDD and Original Applicant = HILL-ROM, INC.