ARKON Anesthesia Delivery System (2018-07-16)

Starting date:

July 16, 2018

Posting date:

August 17, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-67442

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  Reason
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  Affected products

Affected products

ARKON Anesthesia Delivery System

Reason

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.

Affected products