Company: Spacelabs Healthcare, Ltd.
Date of Enforcement Report 8/22/2018
Class II:
PRODUCT
Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and Model #: 99999. This system includes a ventilator. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating room. Recall Number: Z-2589-2018
REASON
Arkon Anesthesia Delivery System may go into a failed state (mechanical ventilation ceases) while the machine is in use or while idle.
RECALLING FIRM/MANUFACTURER
Spacelabs Healthcare, Ltd., Hertford United Kingdom. on 7/11/2018. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
328
DISTRIBUTION
Nationwide and Internationally