ARKON Anesthesia Delivery System (2018-07-16) — recall 58283
Health Canada — Medical Devices · Canada · 2018-08-17 · Type II
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Reported risk: Spacelabs has received reports of the ARKON Anesthesia Delivery System going into a failed state while the machine is in use or while idle. When this occurs, a symbol will be shown on the large display, and a system buzzer will sound. A description of the failed state screen and alarm can be found in the user manual on pages 109 & 234 (070-2410-03, rev b). Emergency oxygen, vaporized agent delivery, and manual ventilation remain available. The anesthesiologist will not have access to mechanical ventilation or the monitoring of ventilation.
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