Recalling Firm / Manufacturer

Hill-Rom, Inc

Product

Hill-Rom Affinity Birthing Bed, Model P3700A

Code Information

All units. (**Affinity beds manufactured with serial number I290AA7395 or greater are not impacted by this correction.)

Reason of 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

Date Recall Initiated

November 21, 2007

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

Contact

AMCO
Riyadh
(01) 4887122

Source of Information

U.S. FDA

SFDA Comments

SFDA urges all hospitals that have devices subjected to recall, to contact the company.