Date Initiated by Firm | June 07, 2013 |
Date Posted | July 19, 2013 |
Recall Status1 |
Terminated 3 on August 29, 2013 |
Recall Number | Z-1771-2013 |
Recall Event ID |
65630 |
510(K)Number | K113051 |
Product Classification |
Ventilator, continuous, facility use - Product Code CBK
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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 United Kingdom
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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 | 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 |
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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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