Z-2082-2012 Class II Terminated

Recalled by Hill-Rom, Inc. — Batesville, IN

FDA device recall Z-2082-2012 was initiated by Hill-Rom, Inc. on Apr 2, 2012 and is designated Class II. Reason for recall: During review of our last braking system via that field corrective action, the system still did not meet our expectations, which is to eliminate the hazards of patient falling. Bed movement… The recall status is terminated (terminated Jul 21, 2015). Affected quantity: 12,726 devices.

Recall Details

Product Type
Devices
Report Date
Aug 1, 2012
Initiation Date
Apr 2, 2012
Termination Date
Jul 21, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12,726 devices

Product Description

Affinity Four Birthing Bed P3700 Product Usage: The Affinity, Four Birthing Bed 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. They are not intended for use as general hospital beds.

Reason for Recall

During review of our last braking system via that field corrective action, the system still did not meet our expectations, which is to eliminate the hazards of patient falling. Bed movement immediately prior to, or during the birthing process may still create distractions and delays, resulting in patient or caregiver falls, or contribute to a deviation in a procedure, (e.g. IV insertion, epidural

Distribution Pattern

Worldwide Distribution - US Nationwide and countries including: Argentina , Aruba, Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Brazil, Brunei, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Guam, Guyana, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Lebanon, Libya, Malaysia, Mauritius, Mexico, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Turkey, Turks and Caicos Islands, United Arab Emirates, United Kingdom, United States, US Virgin Islands, Venezuela and Vietnam

Code Information

Affinity Four Birthing Beds (P3700) manufactured with Serial Numbers H331AA4785 thru N081AA7966

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-2082-2012
openFDA file date
Oct 26, 2026
Loaded by RegDataLab
Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.