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.
This recall has been terminated (originally issued September 1, 2014).
- Company
- Hill-Rom, Inc.
- Recall Initiated
- June 26, 2014
- Posted
- September 1, 2014
- Terminated
- July 14, 2017
- Recall Number
- Z-2562-2014
- Quantity
- 13,000 units
- Firm Location
- Batesville, IN
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
Model #'s: P3700B, P3700C, P3700D and P3700E
Root Cause
Nonconforming Material/Component
Action Taken
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.