| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00735-1 |
| Product Name/Description |
Horizon Cardiology Hemo1 – versions 12.2 HF4 and earlier
(used for acquiring, displaying and reviewing haemodynamic parameters (vital signs) in cardiac catheterisation laboratories)
ARTG number: 146573 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/07/2014 |
| Responsible Entity |
|
| Reason/Issue |
McKesson has identified that its communication to customers regarding the required maintenance tests was insufficient. While each unit has an attached sticker indicating the date of the next maintenance test the need for performing annual maintenance testing is not reiterated in 12.2 HF4 and earlier versions of the Horizon Cardiology Hemo user guides. If the parameter boxes are not calibrated, the Horizon Cardiology Hemo system may not function properly or potentially affect the accuracy of clinical parameters. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Users are advised that the new version of the User Guide (12.2 version 5.0) is now available to address this issue and will be provided electronically upon request. The attachment provided with the customer letter identifies the updated sections of the new User Guide related to annual maintenance testing. This action has been closed-out on 02/02/2016. |
| Contact Information |
1300 338 423 - Device Technologies Australia Pty Ltd |