| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00962-1 |
| Product Name/Description |
Horizon Cardiology Hemo – versions 13.0 and 13.1 (cardiology/cath lab information management system)
ARTG Number: 146573 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
4/09/2014 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has identified two scenarios in which the McKesson Cardiology Hemo calculation section incorrectly converts the Haemoglobin value before it is utilized in the applicable formula calculations. As a result, the formula output is incorrect. If the issue occurs, then for those procedures that use the specified formula calculations, the formula outputs will be incorrect. This may lead to delay in appropriate treatment or incorrect
treatment. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
McKesson will provide a resolution to this issue through a software update. A system check will also take place to identify any previous procedure calculations that may have been affected in your facility. Until the correction is completed additional procedures to ensure correct Hb values are requested to be carried out by end users. This action has been closed-out on 07/06/2016. |
| Contact Information |
02 9975 5755 - Device Technologies Head Office |