Class 2 Device Recall Arkon Anesthesia Delivery System, Model 99999.

• Date Initiated by Firm: February 08, 2017
• Create Date: March 14, 2017
• Recall Status: Terminated on October 19, 2017
• Recall Number: Z-1460-2017
• Recall Event ID: 76429
• 510(K)Number: K113051
• Product Classification: Ventilator, continuous, facility use - Product Code CBK
• Product: 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.
• Code Information: US Serial numbers: ARKN-000003, ARKN-000004, ARKN-000011, ARKN-000012, ARKN-000013, ARKN-000014, 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, ARKN-000031, ARKN-000037, ARKN-000038, ARKN-000039, ARKN-000040, ARKN-000041, ARKN-000042, ARKN-000044, ARKN-000045, ARKN-000046, ARKN-000047, ARKN-000048, ARKN-000049, ARKN-000051, ARKN-000054, ARKN-000055, ARKN-000056, ARKN-000057, ARKN-000058, ARKN-000059, ARKN-000060, ARKN-000061, ARKN-000062, ARKN-000063, ARKN-000064, ARKN-000065, ARKN-000066, ARKN-000067, ARKN-000068, ARKN-000069, ARKN-000070, ARKN-000071, ARKN-000072, ARKN-000073, ARKN-000074, ARKN-000075, ARKN-000076, ARKN-000077, ARKN-000078, ARKN-000082, ARKN-000091, ARKN-000092, ARKN-000093, ARKN-000094, ARKN-000095, ARKN-000096, ARKN-000097, ARKN-000098, ARKN-000099, ARKN-000100, ARKN-000101, ARKN-000102, ARKN-000103, ARKN-000104, ARKN-000105, ARKN-000106, ARKN-000107, ARKN-000108, ARKN-000109, ARKN-000110, ARKN-000111, ARKN-000112, ARKN-000113, ARKN-000114, ARKN-000115, ARKN-000116, ARKN-000117, ARKN-000119, ARKN-000120, ARKN-000123, ARKN-000129, ARKN-000130, ARKN-000132, ARKN-000133, ARKN-000134, ARKN-000135, ARKN-000136, ARKN-000137, ARKN-000138, ARKN-000139, ARKN-000140, ARKN-000141, ARKN-000142, ARKN-000143, ARKN-000144, ARKN-000145, ARKN-000149, ARKN-000150, ARKN-000151, ARKN-000152, ARKN-000153, ARKN-000154, ARKN-000155, ARKN-000157, ARKN-000167, ARKN-000168, arkn-000169, arkn-000170, ARKN-000171, arkn-000173, arkn-000174, arkn-000175, arkn-000176, arkn-000177, arkn-000178, arkn-000179, arkn-000180, arkn-000181, arkn-000182, arkn-000183, arkn-000184, arkn-000185, ARKN-000186, ARKN-000187, ARKN-000188, ARKN-000189, ARKN-000190, ARKN-000191, ARKN-000192, ARKN-000193, ARKN-000194, ARKN-000196, ARKN-000197, ARKN-000198, ARKN-000199, ARKN-000200, ARKN-000201, ARKN-000202, ARKN-000203, ARKN-000204, ARKN-000205, ARKN-000206, ARKN-000207, ARKN-000208, ARKN-000209, ARKN-000210, ARKN-000211, ARKN-000212, ARKN-000213, ARKN-000214, ARKN-000215, ARKN-000216, ARKN-000217, ARKN-000220, ARKN-000221, ARKN-000222, arkn-000223, arkn-000224, arkn-000226, arkn-000227, arkn-000229, arkn-000230, arkn-000231, arkn-000232, arkn-000233, ARKN-000236, arkn-000237, arkn-000238, arkn-000239, arkn-000240, arkn-000241, arkn-000242, arkn-000243, arkn-000244, ARKN-000245, arkn-000248, arkn-000249, ARKN-000250, ARKN-000251, ARKN-000252, ARKN-000253, arkn-000254, arkn-000257, arkn-000258, ARKN-000259, ARKN-000260, arkn-000261, ARKN-000262, arkn-000263, arkn-000264, arkn-000266, arkn-000269, arkn-000270, arkn-000271, arkn-000272, arkn-000273, arkn-000274, arkn-000275, arkn-000276, arkn-000277, ARKN-000278, ARKN-000279, ARKN-000280, ARKN-000281, ARKN-000282, ARKN-000283, ARKN-000284, ARKN-000285, ARKN-000286, ARKN-000287, ARKN-000288, ARKN-000289, ARKN-000290, ARKN-000293, ARKN-000294, ARKN-000295, ARKN-000296, ARKN-000297, ARKN-000300, ARKN-000301, ARKN-000302, ARKN-000303, ARKN-000304, ARKN-000305, ARKN-000306, ARKN-000307, ARKN-000308, ARKN-000309, ARKN-000310, ARKN-000311, ARKN-000312, ARKN-000313, arkn-000314, arkn-000315, arkn-000316, arkn-000317, arkn-000318, ARKN-000319, arkn-000320, arkn-000321, arkn-000322, arkn-000323, arkn-000324, arkn-000325, arkn-000327, arkn-000328, arkn-000329, arkn-000330, ARKN-000332, ARKN-000333, ARKN-000334, ARKN-000335, ARKN-000336, ARKN-000337, ARKN-000338, ARKN-000339, ARKN-000340, ARKN-000341, ARKN-000342, ARKN-000343, ARKN-000344, ARKN-000345, ARKN-000353, ARKN-000360, ARKN-000361, ARKN-000362, ARKN-000363, ARKN-000364, ARKN-000365, ARKN-000366, ARKN-000367, ARKN-000369, ARKN-000370, ARKN-000371, ARKN-000372, ARKN-000373, ARKN-000374, ARKN-000376, ARKN-000377, ARKN-000378, ARKN-000379, ARKN-000380, ARKN-000381, ARKN-000382, ARKN-000383, ARKN-000384, ARKN-000385, ARKN-000386, ARKN-000387, ARKN-000388, ARKN-000389, ARKN-000390, ARKN-000391, ARKN-000392, ARKN-000393, ARKN-000394.ARKN-000395, ARKN-000396, ARKN-000397, ARKN-000398, ARKN-000399, ARKN-000400, ARKN-000401, ARKN-000402, ARKN-000403, ARKN-000404, ARKN-000405, ARKN-000406, ARKN-000407, ARKN-000408, ARKN-000409, ARKN-000410, ARKN-000411, ARKN-000412, and ARKN-000413. ******************************************************************************** INTERNATIONAL SERIAL NUMBERS: ARKN-000001, ARKN-000002, ARKN-000005, ARKN-000010, ARKN-000015, ARKN-000018, ARKN-000032, ARKN-000034, ARKN-000035, ARKN-000052, ARKN-000053, ARKN-000079, ARKN-000081, ARKN-000083, ARKN-000084, ARKN-000085, ARKN-000086, ARKN-000087, ARKN-000089, ARKN-000090, ARKN-000121, ARKN-000131, ARKN-000146, ARKN-000147, ARKN-000148, ARKN-000156, ARKN-000158, ARKN-000159, ARKN-000160, ARKN-000161, ARKN-000162, ARKN-000163, ARKN-000164, ARKN-000165, ARKN-000166, ARKN-000172, arkn-000218, arkn-000219, Arkn-000225, arkn-000234, arkn-000235, ARKN-000255, ARKN-000256, ARKN-000268, ARKN-000291, ARKN-000292, ARKN-000298, ARKN-000299, ARKN-000326, ARKN-000331, ARKN-000346, ARKN-000347, ARKN-000348, ARKN-000349, ARKN-000350, ARKN-000351, ARKN-000352, ARKN-000354, ARKN-000355, ARKN-000356, ARKN-000357, ARKN-000358, ARKN-000359, ARKN-000368, ARKN-000375, ARKN-000414, ARKN-000415, ARKN-000416, ARKN-000417, ARKN-000418, ARKN-000419, ARKN-000420, ARKN-000421, ARKN-000422, ARKN-000423, and ARKON-000088.
• Recalling Firm/ Manufacturer: Del Mar Reynolds Medical, Ltd.; 1 2 Harforde Court John Tate Road; Business Park; Hertford United Kingdom
• For Additional Information Contact: Technical Support; 425-363-5212
• Manufacturer 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.
• FDA Determined Cause: Software design
• 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.
• Quantity in Commerce: 325 devices sold to 35 US consignees and 76 devices sold to 14 international consignees
• Distribution: 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.
• 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