| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00606-1 |
| Product Name/Description |
McKesson Cardiology and Change Healthcare Cardiology
Affected software versions: 14.0, 14.1.1, 14.2, 14.3.2, 15.0.1
ARTG 321854
(Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Information system, cardiology) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/07/2024 |
| Responsible Entity |
|
| Reason/Issue |
Emergo Australia is informing of an incorrect configuration of date settings which may lead to incorrect procedure date documentation.
The occurrence of unapproved configurations is more likely in areas where there is a cultural preference or a regional practice of using different date formats.
When the unapproved configuration is being used, manual editing of procedure details in Change Healthcare Cardiology Web™ may result in unintentional swapping of the day and month values of the procedure date.
This problem arises due to differences between the local computer’s date format settings and the system’s date format settings, resulting in an incorrect documentation of the procedure date: the month and day being incorrectly switched.
While the current labelling (Web Clients Installation Guide 15.0 GUD-10130 rev. 6.0) includes specific instructions to ensure regional settings are properly aligned, prior versions of the labelling did not explicitly include this information. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
The customers should assess if they are affected by the problem.
If they are working in an environment where the server locale and client locale are configured differently, or if they have observed that the numeric values for months and days in dates may be switched, the customer should ensure that the date format settings are consistent.
In case the customer finds that the unsupported configuration is in use, they are required to contact support for further instruction. |
| Contact Information |
02 9006 1662 - AUNZvigilance@ul.com - Emergo Australia |