Health Canada — Medical Devices · Canada · 2024-10-16 · Type II
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Reported risk: Olympus is conducting this medical device recall after identifying an increase in complaints indicating an occurrence of system error e1226 "could not write to audio buffer" during procedures using the ESG-410 (Sep). This error is a high priority alarm which triggers an automatic reboot of the device, which may lead to a delayed or interrupted procedure until the reboot is completed. Rebooting is a safety measure to put the generator back into safe operation. After the reboot, the procedure can be continued. Olympus has developed a software update that prevents this system error e1226 from unnecessarily occurring. Olympus has received six (6) complaints for the ESG-410 (sep) generator with the occurrence of system error e1226. No serious injuries or reportable malfunctions have been reported in relation to this issue. Recall start date: October 1, 2024
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