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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00713-1
Product Name/Description Affinity Four Birthing Bed

Part Number: (P3700B/C/D/E)

Production dates: October 2006 through June 2014

ARTG Number: 151145
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 4/07/2014
Responsible Entity Hill-Rom Pty Ltd
Reason/Issue Hill-Rom would like to remind users of proper handling of the Lift-Off foot section per the Affinity Four Birthing Bed manual. Improper handling, such as allowing the foot section to be dropped repeatedly, could cause the attachment latch mechanism to become bent. If the latch mechanism is bent badly enough, it could potentially cause the installed foot section to be improperly engaged onto the bed. If the damaged foot section should disengage during use, this could result in injury to the user due to a fall.
Recall Action Recall for Product Correction
Recall Action Instructions Hill-Rom is highlighting key instructions in the operator's manual and providing additional instructions to end users to verify if the Lift-Off foot sections have enough engagement. A change to the Lift-Off foot section is currently in development to mitigate the issue.
Contact Information 1800 147 118 - Hill-Rom Technical Support