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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 050904300see related information
Date Initiated by FirmOctober 11, 2017
Date PostedNovember 21, 2017
Recall Status1 Terminated 3 on March 12, 2018
Recall NumberZ-0072-2018
Recall Event ID 78330
510(K)NumberK113051 
Product Classification Gas-machine, anesthesia - Product Code BSZ
ProductArkon 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
ActionSpacelabs 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 Commerce110 units
DistributionNationwide Distribution to the states of NM, WY, FL, NC, MS, CO, CT, ME, and AL.
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = BSZ
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