| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00253-1 |
| Product Name/Description |
AvantGuard 1600 Li160A0
(Hospital bed)
Models: CS160A0005XXX & PRS160A0005XXX
Serial Numbers: HRP001288830 to HRP002497322
Manufactured between June 2009 and December 2015.
ARTG number: 127268 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
8/03/2016 |
| Responsible Entity |
|
| Reason/Issue |
Hill-Rom has received reports that the backrest actuator on the AvantGuard 1600 beds may experience a jolted motion, noise (clanking or chattering), premature wear, or backrest functionality loss when a load is applied to the backrest section. These issues do not affect the CPR functionality in case of emergency.
The reported issue is unlikely to cause adverse health consequences. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Hill-Rom has developed a correction and will contact the affected facilities to modify the affected beds. The CPR function is still operational in case of emergency. For this reason, the device can continue to be used whilst awaiting the correction. If however, the unit experiences a loss of backrest functionality, users are advised to take it out of service and contact Hill-Rom.
This action has been closed out on 6/09/2018. |
| Contact Information |
1800 445 576 - Hill-Rom |