Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recoding System. The affected devices are identified as follows:-
The manufacturer has received complaints indicating that, when using the blood pressure channels on the CLEARSIGN II Amplifier, the surface Electrocardiogram (ECG) channels become overwritten to a variable degree, with the result that it appears shifted from baseline on the system's output screen. This may manifest as an uninterpretable ECG signal in the affected channel. According to the manufacturer, there have been no reports of patient injury related to this firmware issue and it does not pose a risk to the patient.
The manufacturer will upgrade the firmware.
According to the local supplier, the affected products are not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 8 June 2015