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 |
|
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 |