| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00289-1 |
| Product Name/Description |
Alaris System PC Unit model 8015
Material Codes: 8015LSBIXEN9121; 8015LSAIXE9121; 8015LSCIXE91240; 12279909
Manufactured between September 1, 2012 and October 22, 2013 having a 5.7” screen
ARTG Number: 146666 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
31/03/2015 |
| Responsible Entity |
|
| Reason/Issue |
CareFusion USA (the manufacturer) has identified an issue with the PC Unit Model 8015 following receipt of reports from customers experiencing a system error. A system error (code 110.6021) is displayed with concurrent audio and visual alarm, however it cannot be cleared by restarting or rebooting the PC unit. The error code may occur upon power on during the “Power-On Self Test” due to a keypad issue. The Power-On Self Test is designed to occur during power on, in order to detect issues prior to initiation of an infusion. The system cannot be cleared by restarting or rebooting the PC unit.. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
CareFusion will replace the affected front keypad assembly on the Alaris PC unit. In the interim end users have been provided with work around instructions to minimise risk to patients. This action has been closed-out on 12/08/2016. |
| Contact Information |
1800 833 372 - CareFusion Customer Service |