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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76429

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 08, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Del Mar Reynolds Medical, Ltd.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1460-2017
Recall number
Z-1460-2017
Initiated
February 08, 2017
Classification
Class II
Status
Terminated
Quantity
325 devices sold to 35 US consignees and 76 devices sold to 14 international consignees

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

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.

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.