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Terminated

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. The device is intended for use only by a suitably qualified physician

FDA Recall Z-0072-2018 · Posted 2017-11-21

Recalling FirmSpacelabs Healthcare, Ltd.
Recall StatusTerminated
Product CodeBSZ
Date Initiated2017-10-11
Date Terminated2018-03-12
Product Quantity110 units

Reason for Recall

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.

Firm Action

Spacelabs Healthcare sent an Urgent Medical Device Correction letter dated October 24, 2017. The letter identified the affected product problem and actions to be taken. For questions call 1-800-522-7025 and select 4 for Technical Support.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution to the states of NM, WY, FL, NC, MS, CO, CT, ME, and AL.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K113051SPACELABS ARKON ANESTHESIA WORKSTATIONSpacelabs Healthcare · 2012-03-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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