| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00912-1 |
| Product Name/Description |
HScribe, RScribe, Welch Allyn Diagnostic Cardiology Suite, and XScribe
HScribe
Software Version: V6.1.0 – V6.4.1
Release date: 02-Aug-2016
RScribe
Software Version: V6.0.0 – V6.2.3
Release date: 02-Jul-2015
Welch Allyn Diagnostic Cardiology Suite
Software Version: V2.1.0
Release date: 12-Aug-2019
XScribe
Software Version: V6.0.0 – V6.3.2
Release date: 02-Jul-2015
ARTG's 327826, 324982, 324984, 324622 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/10/2024 |
| Responsible Entity |
|
| Reason/Issue |
Baxter Healthcare is issuing a Product Defect Correction for the HScribe, RScribe, Welch Allyn Diagnostic Cardiology Suite and XScribe products due to the potential for exam files being assigned duplicate Unique Identifiers (UIDs).
This problem could lead to a mismatch of the patient’s identification with their physiological data. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
1. Customers are to contact the system IT administrator to confirm that their system is impacted by this problem. This action is only necessary if the interfacing system (e.g., PACS) is configured to receive DICOM results and relies solely on the UID for results - patient/order matching.
2. For the products HScribe V6.1.0 – V6.4.1, RScribe V6.0.0 – V6.2.3, XScribe V6.0.0 – V6.3.2 a correction can be implemented by the system IT administrator to address this problem and is already available in customers current version of software. The New Series Instance UID option will need to be activated. Baxter will work with customers to confirm, if applicable, that the correction has been implemented.
3. For the Welch Allyn Diagnostic Cardiology Suite v2.1.0, customers should contact Baxter Technical Service to request and schedule the correction. |
| Contact Information |
1800 445 576 - Baxter Healthcare Customer Service |