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U.S. Department of Health and Human Services

Class 2 Device Recall Affinity Four Birthing Bed

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  Class 2 Device Recall Affinity Four Birthing Bed see related information
Date Initiated by Firm June 26, 2014
Date Posted September 01, 2014
Recall Status1 Terminated 3 on July 14, 2017
Recall Number Z-2562-2014
Recall Event ID 68650
510(K)Number K915779  
Product Classification Table, obstetric (and accessories) - Product Code KNC
Product Affinity¿ Four Birthing Bed,

Product Usage:
Product is intended to be used as birthing beds for women of child bearing age in an LDR (Labor, Delivery, Recovery) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Labor and Delivery market.
Code Information Model #'s: P3700B, P3700C, P3700D and P3700E
Recalling Firm/
Manufacturer		 Hill-Rom, Inc.
1069 State Road 46 E
Batesville IN 47006-7520
For Additional Information Contact
800-445-3720
Manufacturer Reason
for Recall		 The attachment latch mechanism can become bent depending on user handling. Latch mechanism bending could lead to improper engagement of the foot section and this could result in injury to the user due to a fall.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Hill-rom issued an Urgent Field Safety Notice letter dated June 26, 2014 to affected customers. The Notification identified the affected product issue and instructions for product inspection. The letter states that the firm is working on making changes to the Lift-Off foot section that will mitigate risk even if damage was to occur. If you have any questions concerning the notice or requested procedure, please contact Hill-Rom Technical Support at 800-445-3720.
Quantity in Commerce 13,000 units
Distribution Worldwide Distribution - US Nationwide and the following countries: Argentina , Aruba, Australia, Austria, Bahamas, Bahrain, Belgium, Belize, Bermuda, Brazil, Brunei, Bulgaria, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Equatorial Guinea, Finland, France, Germany, Greece, Guam, Guyana, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Lebanon, Libya, Malaysia, Mauritius, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turks and Caicos Islands, United Arab Emirates, United Kingdom, US Virgin Islands, Venezuela and Vietnam.
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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