Z-0582-2008

Hill-Rom Affinity Two Birthing Bed, Model P3600

Name: Z-0582-2008 Hill-Rom Affinity Two Birthing Bed, Model P3600
Creator: Hill-Rom, Inc.
Published: 2007-11-21
License: https://open.fda.gov/license/

Hill-Rom Inc. / initiated 2007-11-21 / Terminated / root cause: design

FDA source

Hill-Rom, Inc. began a recall of Hill-Rom Affinity Two Birthing Bed, Model P3600 on 2007-11-21. The reason FDA records is "Hole/opening on the labor bar -- Amputation of a finger could result, if a finger is placed into the opening, as the hole/opening creates a shear point when the mechanism is activated". 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-0582-2008
Status: Terminated
Initiated: 2007-11-21
Posted: 2008-02-22
Terminated: 2009-09-22
Recalling firm: Hill-Rom Inc.
Product: Hill-Rom Affinity Two Birthing Bed, Model P3600.
Product code: KNC Table, Obstetric (And Accessories)
Reason for recall: Hole/opening on the labor bar -- Amputation of a finger could result, if a finger is placed into the opening, as the hole/opening creates a shear point when the mechanism is activated.
Root cause tag: design
FDA root cause: Device Design
Action: Consignees were notified of the problem via an Urgent Medical Device Correction letter dated 11/21/07. Users were informed that they would be receiving a free upgrade kit for all of their Affinity Birthing Beds. The Kit includes two plugs per bed, an insertion tool, and full written instructions. An instruction video is available at www.Hill-Rom.com.
Quantity in commerce: 32,379 for all model numbers
Distribution: Worldwide Distribution-- including USA and countries of Argentina, Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Brazil, Brunei, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Dominican Republic, Egypt, Finland, France, Germany, Greece, Guam, Honduras, Hong Kong, Hungary, Iceland, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Lebanon, Malaysia, Mexico, Morocco, The Netherlands, New Calidonia, New Zealand, Nigeria, Northern Mariana Islands, Norway, Oman, Panama, Philippines, Poland, Portugal, Qatar, Republic of Korea, Saudi Arabia, Singapore, South Korea, Romania, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguey, Venezuela, and Virgin Islands .
Product codes and lots: All units. (**Affinity beds manufactured with serial number I290AA7395 or greater are not impacted by this correction.)

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)