| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01459-1 |
| Product Name/Description |
Xhibit Central Station, software version 1.1.5
Serial Numbers: SLA1015F00831, SLA0916F02109
ARTG Number: 237776 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
16/11/2016 |
| Responsible Entity |
|
| Reason/Issue |
Reports have been received of telemetry SpO2 numerics dropping off the Xhibit Central display when using software version 1.1.5 with connectivity to telemetry. Desaturation, high, and low limit alarms work normally. This problem can occur when the Xhibit Central Station software version 1.1.5 is used in conjunction with a Telemetry Receiver for purposes of remote patient monitoring.
Ecomed Pty Ltd has not supplied any Telemetry Receiver medical devices to the Australian hospitals that are connected to software version 1.1.5 of Xhibit Central Station. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Although there is no product affected in Australia, product correction is being undertaken by Ecomed Pty Ltd to support potential future use of telemetry functionality with the Xhibit Central System in relevant Australian hospitals. Ecomed will be contacting affected customers to perform a software update. This action has been closed-out 11/05/2017. |
| Contact Information |
1800 675 432 - EcoMed |