Arkon Anesthesia Delivery System, Model 99999. Product Usage: Continuous Ventilator The Arkon Anesthesia Delivery System is designed to provide emergency oxygen, vaporized agent delivery and manual ventilation in the event of a power failure scenario. Clinicians are able to use Emergency O2 and manually ventilate the patient, providing gas and agent. However, the anesthesiologist will not have access to mechanical ventilation or ventilator monitoring.
FDA Recall Z-1460-2017 · Posted None
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Recalling FirmDel Mar Reynolds Medical, Ltd.
Recall StatusTerminated
Product CodeCBK
Date Initiated2017-02-08
Date Terminated2017-10-19
Product Quantity325 devices sold to 35 US consignees and 76 devices sold to 14 international consignees
Reason for Recall
Spacelabs has received reports of the Arkon Anesthesia Delivery System, Model 99999, shutting down without warning. The power supply has failed in a way that does not trigger the normal on battery alarms.
Firm Action
On 08 February 2017, a customer letter will be sent via priority service, return receipt requested, to all U.S. customers. Records of notification will be maintained to ensure complete notification.
On 15 February 2017, a customer letter (translated as necessary) will be emailed to all international subsidiaries and distributors of record. Records of notification will be maintained to ensure complete notification.
Upgrade is expected to be available in April 2017; all affected Arkon Anesthesia Delivery Systems will receive a software upgrade onsite.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - US nationwide and internationally in the following countries: BOLIVIA, CANADA, CHINA, ECUADOR, FRANCE, IRELAND, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, PANAMA, PERU, POLAND, UNITED KINGDOM.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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