Medical device manufacturer, Abbott, issued a medical device safety alert concerning its EnSite X Display Workstation with software versions 1.0.1, 1.0.2, and 1.1 [Models: ENSITE-DWS-01, ENSITE-DWS-1.1, ENSITE-R-DWS-01, ENSITE-R-DWS-1.1, ENSITE-SW-1.0.1, ENSITE-SW-1.0.2, ENSITE-SW-1.1; GTINs: 05415067032171, 05415067037725, 05415067032188, 05415067037756, 05415067036575, and 05415067037763].
The manufacturer has received complaints related to errors or irregularities of catheter location when the optional respiration compensation feature was used. There may lead to unstable catheter tracking and uncertainty regarding the location of the catheter in the heart. According to the manufacturer, the respiration compensation feature may not stabilize the catheter location as expected during a procedure (e.g., the image may display excessive catheter movement while the catheter is in a stationary position, or the catheter may appear to shift to a different location). It may result in uncertainty on the actual location of the catheter in the heart. The manufacturer claimed that the issue is more likely to occur when tracking catheters in EnSite NavX mode and has not been reported to present as often in EnSite VoXel mode. Based on the assessment of the manufacturer, the risk associated with this issue is a delay during the procedure with an improbable potential to result in physical harm.
The manufacturer is instructing affected users to take the following actions:
The manufacturer will provide a software upgrade to fix the issue.
According to the manufacturer, the affected devices are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 28 Sep 2021