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U.S. Department of Health and Human Services

Class 2 Device Recall HillRom Affinity Birthing Bed

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  Class 2 Device Recall HillRom Affinity Birthing Bed see related information
Date Initiated by Firm November 21, 2007
Date Posted February 22, 2008
Recall Status1 Terminated 3 on September 22, 2009
Recall Number Z-0582-2008
Recall Event ID 45807
510(K)Number K915779  
Product Classification Obstetric Table and Accessories - Product Code KNC
Product Hill-Rom Affinity Two Birthing Bed, Model P3600.
Code Information All units. (**Affinity beds manufactured with serial number I290AA7395 or greater are not impacted by this correction.)
Recalling Firm/
Manufacturer		 Hill-Rom, Inc.
125 E Pearl St
Batesville IN 47006
For Additional Information Contact
800-445-3730
Manufacturer Reason
for Recall		 Hole/opening on the labor bar -- Amputation of a finger could result, if a finger is placed into the opening, as the hole/opening creates a shear point when the mechanism is activated.
FDA Determined
Cause 2		 Device Design
Action Consignees were notified of the problem via an Urgent Medical Device Correction letter dated 11/21/07. Users were informed that they would be receiving a free upgrade kit for all of their Affinity Birthing Beds. The Kit includes two plugs per bed, an insertion tool, and full written instructions. An instruction video is available at www.Hill-Rom.com.
Quantity in Commerce 32,379 for all model numbers
Distribution Worldwide Distribution-- including USA and countries of Argentina, Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Brazil, Brunei, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Dominican Republic, Egypt, Finland, France, Germany, Greece, Guam, Honduras, Hong Kong, Hungary, Iceland, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Lebanon, Malaysia, Mexico, Morocco, The Netherlands, New Calidonia, New Zealand, Nigeria, Northern Mariana Islands, Norway, Oman, Panama, Philippines, Poland, Portugal, Qatar, Republic of Korea, Saudi Arabia, Singapore, South Korea, Romania, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguey, Venezuela, and Virgin Islands .
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 = KNC and Original Applicant = HILL-ROM, INC.
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