FDA-Device2021-08-04Class II
Affinity Four Birthing Bed-used as a birthing bed 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 Model Numbers: P3700B, P3700C, P3700D, & P3700E
Hill-Rom, Inc.
Hazard
Latch mechanism on the Lift-Off foot section of the Affinity Four Birthing Bed is damaged, it could potentially cause the installed foot section to be improperly engaged onto the bed, could result in injury to the user due to a fall.
Sold states
Worldwide distribution - US Nationwide distribution in the states of AL, CA, IA, MS, NC, NY, OH, PA, TX, VA and the countries of Australia, Austria, Azerbaijan, Belgium, Chile, China, Denmark, Finland, France, Germany, Ireland, Israel, Italy, Jordan, Kuwait, Netherlands, New Zealand, Norway, Portugal, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom.
Affected count
1,096 Beds
Manufactured in
1069 State Road 46 E, N/A, Batesville, IN, United States
Products
Affinity Four Birthing Bed-used as a birthing bed 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 Model Numbers: P3700B, P3700C, P3700D, & P3700E
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2156-2021Don't want to check this manually?
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