Company:Spacelabs Healthcare, Ltd.
Date of Enforcement Report 11/29/2017
Class l:
PRODUCT
Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer.
Recall Number Z-0072-2018
REASON
Arkon Anesthesia Workstation, with software version 2.61, experienced failure in mechanical ventilation, oxygen and anesthetic gas delivery, with concurrent failure of the display unit that resulted in a blank screen without audible or visible alarms
RECALLING FIRM/MANUFACTURER
Spacelabs Healthcare, Ltd., Hertford UK on 10/11/2017. Voluntary firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
110 units
DISTRIBUTION
Nationwide Distribution to the states of NM, WY, FL, NC, MS, CO, CT, ME, and AL.
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