Z-2562-2014 Class II Terminated

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

FDA device recall Z-2562-2014 was initiated by Hill-Rom, Inc. on Jun 26, 2014 and is designated Class II. 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… The recall status is terminated (terminated Jul 14, 2017). Affected quantity: 13,000 units.

Recall Details

Product Type
Devices
Report Date
Sep 10, 2014
Initiation Date
Jun 26, 2014
Termination Date
Jul 14, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13,000 units

Product Description

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.

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 Pattern

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.

Code Information

Model #'s: P3700B, P3700C, P3700D and P3700E

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-2562-2014
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 26, 2026

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