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U.S. Department of Health and Human Services

Class 2 Device Recall Spacelabs ARKON Anesthesia Workstation

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 Class 2 Recall
Spacelabs ARKON Anesthesia Workstation
see related information
Date Posted July 19, 2013
Recall Status1 Terminated on August 29, 2013
Recall Number Z-1771-2013
Recall Event ID 65630
Premarket Notification
510(K) Number
K113051 
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
Product Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation 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.
Code Information ARKN-000001, ARKN-000005, ARKN-000010, ARKN-000015, ARKN-000016, ARKN-000017, ARKN-000018, ARKN-000020, ARKN-000021.
Recalling Firm/
Manufacturer
Del Mar Reynolds Medical, Ltd.
1-2 Harforde Ct., Foxholes
Business Park
Hertford
For Additional Information Contact Technical Support
800-522-7025
Manufacturer Reason
for Recall
Spacelabs ARKON Anesthesia System is recalled due to software defect. The System Status Computer may incorrectly determine that a communication error has occurred. If this situation occurs, a buzzer will activate and a yellow triangle will be displayed on the System Status Computer screen that alerts the user of this error.
FDA Determined
Cause 2
DESIGN: Software Design
Action Spacelabs Healthcare sent an Urgent Medical Device Correction" letter, dated June 20, 2013, to all affected consignees. The letter identified the product, th problem, and the action to be taken by the consignee. Consignees were instructed to advise their staff of the situation. Consignees were also advised that Spacelabs Field Service personnel would be contacting them at their facility to schedule installation of a software update to resolve the issue at not cost to the consignee. Consignees with questions were instructed to call Technical Support at 1-800-522-7025 and select option 2. For questions regarding this recall call 800-522-7025.
Quantity in Commerce 9 units (4 in the US and 5 outside US)
Distribution Worldwide Distribution - USA including South Carolina and internationally to Canada and Great Britian.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = SPACELABS HEALTHCARE
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