Z-2562-2014Class II

Affinity Four Birthing Bed

Name: Z-2562-2014 Affinity Four Birthing Bed
Creator: Hill-Rom, Inc.
Published: 2014-06-26
License: https://open.fda.gov/license/

Hill-Rom Inc. / initiated 2014-06-26 / Terminated / root cause: manufacturing process

FDA source

Hill-Rom, Inc. began a recall of 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)... on 2014-06-26. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2562-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-26
Posted: 2014-09-01
Terminated: 2017-07-14
Recalling firm: Hill-Rom Inc.
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.
Product code: KNC Table, Obstetric (And Accessories)
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Model #'s: P3700B, P3700C, P3700D and P3700E

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2562-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2562-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-10	2014-09-01

Product code KNC

K915779Class IIAffinity Bed Model 3600 SeriesHill-Rom, Inc. / cleared 1993-02-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)