| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00941-1 |
| Product Name/Description |
Progressa Bed System with European (OIML) Version Scale
All Progressa Beds manufactured prior to 16 May 2016 containing European (OIML) Version Scale
Model Number: P7500
Serial Numbers: S1 12234946, S1 11791226 and O277AW0635
ARTG Number: 221346 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/07/2016 |
| Responsible Entity |
|
| Reason/Issue |
Hill-Rom has become aware of a potential software issue with some Progressa beds equipped with the European (OIML) version scale. The issue affects how the air system utilises data from the scale to set bladder pressure points. If the software does not convert the patient weight to the air system correctly, then in some cases the pressure setting of the bladders may be higher or lower than the optimal pressure range. In some cases, patients that are already high risk may become more susceptible to pressure ulcers. This issue does not affect the accuracy or calibration of the Progressa scale weighing function. The likelihood of occurrence is less than 57/100,000 units. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Hill-Rom will be providing an upgrade to the software of the affected units. The upgrade allows for improved scale communications with the surface and system software, and will not affect how the scale and bed are operated. In the interim, Progressa beds equipped with the European (OIML) Version Scale may continue to be used while maintaining proper patient positioning practices.
This action has been closed out on 15/11/2018 |
| Contact Information |
1800 445 576 - Hill-Rom Technical Service Direct |