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U.S. Department of Health and Human Services

Class 1 Device Recall Arkon Anesthesia Delivery System

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  Class 1 Device Recall Arkon Anesthesia Delivery System see related information
Date Initiated by Firm March 10, 2014
Date Posted April 12, 2014
Recall Status1 Terminated 3 on August 20, 2014
Recall Number Z-1442-2014
Recall Event ID 67781
510(K)Number K113051  
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.
Code Information SERIAL NUMBERS OF UNITS DISTRIBUTED IN THE US:  ARKN-000011, ARKN-000016, ARKN-000017, ARKN-000019, ARKN-000020, ARKN-000021, ARKN-000022, ARKN-000023, ARKN-000024, ARKN-000025, ARKN-000026, ARKN-000027, ARKN-000028, ARKN-000029, ARKN-000030, and ARKN-000031.
Recalling Firm/
Manufacturer		 Del Mar Reynolds Medical, Ltd.
1-2 Harforde Ct., Foxholes
Business Park
Hertford United Kingdom
For Additional Information Contact
800-522-7025 Ext. 2
Manufacturer Reason
for Recall		 The System may go into a controlled failed state if a series of parameters on the user interface are activated in a specific sequence.
FDA Determined
Cause 2		 Software in the Use Environment
Action Spacelabs Healthcare sent an Urgent Medical Device Correction letter, dated 11 March 2014, to consignees. The letter identified the product, the problem, and the actions to be taken by the customer. The letter stated that Spacelabs Field Service personnel will be contacting consignees to schedule a convenient time to install, at no cost, a software upgrade. Consignees with questions about this corrective action program, please contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.
Quantity in Commerce 16 units distributed in the US
Distribution USA Nationwide Distribution in the states of North Carolina and South Carolina
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = SPACELABS HEALTHCARE
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