Progressa Bed System with European (OIML) Version ScaleAll Progressa Beds manufactured prior to 16 May 2016 containing European (OIML) Version Scale 의 리콜

Recall

RC-2016-RN-00941-1

Class II

2016-07-22

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00941-1

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.

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.