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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 FirmSeptember 06, 2007
Date PostedApril 02, 2008
Recall Status1 Terminated 3 on October 15, 2010
Recall NumberZ-0617-2008
Recall Event ID 45444
510(K)NumberK915779 
Product Classification Birthing Bed - Product Code HDD
ProductHill-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/
Manufacturer		 Hill-Rom, Inc.
125 E Pearl St
Batesville IN 47006
For Additional Information Contact
800-445-3720
Manufacturer Reason
for Recall		Brake failure: The brakes may not hold or lock properly.
FDA Determined
Cause 2		Component design/selection
ActionHill-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 Commerce1,796
DistributionWorldwide 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 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.
510(K) Database510(K)s with Product Code = HDD
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