Terminated

Hill-Rom Affinity Birthing Bed, Model P3600.

FDA Recall Z-0581-2008 · Posted 2008-02-22

Recalling FirmHill-Rom, Inc.

Recall StatusTerminated

Product CodeKNC

Date Initiated2007-11-21

Date Terminated2009-09-22

Product Quantity32,379 for all model numbers

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

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 .

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K915779AFFINITY BED MODEL 3600 SERIESHill-Rom, Inc. · 1993-02-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.