| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00786-1 |
| Product Name/Description |
ArjoHuntleigh Flowtron ACS900 Active Compression System
Flowtron ACS900 pumps manufactured between 26 Sept 2014 and 20 Dec 2016 with software V1.099
Serial Number range: 1400028031 to 1600048470
ARTG Number: 254916 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
26/06/2017 |
| Responsible Entity |
|
| Reason/Issue |
ArjoHuntleigh has identified that in some instances specific ACS900 pumps will constantly deliver pressure to the garment without triggering the alarm. An investigation has concluded that the consistent flow of pressure to the garment without deflation may lead to a potential risk of injury to patients. ArjoHuntleigh has received a limited number of complaints regarding this specific state. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
ArjoHuntleigh is requesting that customers:
1. Ensure that all caregivers and users of the ArjoHuntleigh Flowtron ACS900 pump are made aware of this recall for product correction and that all listed devices at their facility are available to be upgraded during the service technician visit;
2. Complete, sign and return the Customer Response Form to ArjoHuntleigh.
Note: ArjoHuntleigh will contact the designated facility representative listed on the Customer Response Form to schedule service to upgrade the software on all listed devices, free of charge.
This action has been closed out on 11/10/2018 |
| Contact Information |
1800 072 040 - ArjoHuntleigh |