Z-0617-2008

Hill-Rom Affinity 4 Birthing Bed; Model P3700B, Hill-Rom, Inc., Batesville, IN 47006

Name: Z-0617-2008 Hill-Rom Affinity 4 Birthing Bed; Model P3700B, Hill-Rom, Inc., Batesville, IN 47006
Creator: Hill-Rom, Inc.
Published: 2007-09-06
License: https://open.fda.gov/license/

Hill-Rom Inc. / initiated 2007-09-06 / Terminated / root cause: design

FDA source

Hill-Rom, Inc. began a recall of Hill-Rom Affinity 4 Birthing Bed; Model P3700B, Hill-Rom, Inc., Batesville, IN 47006 on 2007-09-06. The reason FDA records is "Brake failure: The brakes may not hold or lock properly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0617-2008
Status: Terminated
Initiated: 2007-09-06
Posted: 2008-04-02
Terminated: 2010-10-15
Recalling firm: Hill-Rom Inc.
Product: Hill-Rom Affinity 4 Birthing Bed; Model P3700B, Hill-Rom, Inc., Batesville, IN 47006
Product code: HDD Table, Obstetrical, Ac-Powered (And Accessories)
Reason for recall: Brake failure: The brakes may not hold or lock properly.
Root cause tag: design
FDA root cause: Component design/selection
Action: Hill-Rom notified consignees via Urgent Medical Device Correction letter dated 9/6/07. The letter instructed facilities to continue using the beds if they pass a test of the brake mechanism; and a Hill-Rom representative will contact the facility to schedule a replacement of the detent mechanism and adjustment of the casters.
Quantity in commerce: 1,796
Distribution: Worldwide Distribution - USA, Argentina, Australia, Bahamas, Belgium, Belize, Brazil, Canada, China, Denmark, Dominican Republic, France, Germany, Guam, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Jordan, Kenya, Malaysia, Mexico, Netherlands, Norway, Philippines, Russia, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Syria, Turkey, United Arab Emirates and United Kingdom.
Product codes and lots: All units manufactured prior to 11/20/07; all beds with serial numbers below 1232AA6856.

Product code HDD

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)