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U.S. Department of Health and Human Services

Class 1 Device Recall Arkon Anesthesia Delivery System and Upgrade Kit 050904300

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  Class 1 Device Recall Arkon Anesthesia Delivery System and Upgrade Kit 050904300 see related information
Date Initiated by Firm October 11, 2017
Create Date November 21, 2017
Recall Status1 Open3, Classified
Recall Number Z-0072-2018
Recall Event ID 78330
510(K)Number K113051  
Product Classification Gas-machine, anesthesia - Product Code BSZ
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. The device is intended for use only by a suitably qualified physician
Code Information UDI: 10841522100017
Recalling Firm/
Manufacturer
Spacelabs Healthcare, Ltd.
Foxholes Centre, Unit B
John Tate Road
Hertford United Kingdom
Manufacturer 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.
FDA Determined
Cause 2
Software design
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.
Quantity in Commerce 110 units
Distribution Nationwide Distribution to the states of NM, WY, FL, NC, MS, CO, CT, ME, and AL.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = BSZ and Original Applicant = SPACELABS HEALTHCARE
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