| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-01008-1 |
| Product Name/Description |
E-Scribe
ENG 220V, ENTERPRISE KIT EXP
Product: ESCRIBE-AAB-CXXAX
Lot: 108440008170
ENG 220V, DEPARTMENT KIT
Product: ESCRIBE-AAB-CXXXX
Lot: 109150017631
ENG ENTERPRISE 220V SW KIT
Product: ESCRIBE-BAB-CXACB
Lot: 117300580360
ESCRIBE RX ENG 220V KIT
Product: ESCRIBE-CAB- CXACA
Lot: 118400000316
ESCRIBE RX ENG 220V KIT
Product: ESCRIBE-CAB- CXACA
Lot: 118400000317
ENG 220V KIT RX EXPANDED
Product: ESCRIBE-CAB- CXACB
Lot: 111390094289
ARTG 165822 & 324407 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/11/2023 |
| Responsible Entity |
|
| Reason/Issue |
Baxter Healthcare is communicating important safety information regarding the use of E-Scribe software.
Baxter is issuing a Customer Service Bulletin to all customers in Australia to communicate the risk of critical security vulnerabilities with the use of E-Scribe.
Baxter will be ending sale of E-Scribe with a limited support window ending 1st August 2025 for Clinical Research Organization customers, and 1st February 2024 for all other customer types.
The affected product was distributed between 7th April 2018 to 19th March 2023 in Australia.
Only 1 complaint since 2008 has been reported, however, there have been no reports of adverse events related to this issue.
The security vulnerabilities impacting E-Scribe may potentially lead to security and patient safety risks including modification of patient data. This manipulation of patient data could possibly lead to incorrect treatment, misdiagnosis, or delay of care. |
| Recall Action |
Product Defect Alert |
| Recall Action Instructions |
Customers are advised to stop using E-Scribe due to critical security vulnerabilities impacting E-Scribe.
If customers wish to continue use of the product, the Technical Service Bulletin will provide some mitigating control measures (Security Risk Control Measures).
Baxter will provide technical support for the product sold to customers until 1st February 2024 and product sold to Clinical Research Organisations until 1st August 2025.
Technical support can be reached at 1.888.667.8272. |
| Contact Information |
1.888.667.8272 - Baxter Healthcare Pty Ltd |