| Class 1 Device Recall Arkon Anesthesia Delivery System | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = CBK
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