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U.S. Department of Health and Human Services

Class 2 Device Recall Viterion V500 Telehealth Monitors

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 Class 2 Device Recall Viterion V500 Telehealth Monitors see related information
Date Posted February 14, 2013
Recall Status1 Open
Recall Number Z-0822-2013
Recall Event ID 64111
510(K)Number K004050 
Product Classification Monitor,physiological,patient(without arrhythmia detection or alarms) - Product Code MWI
Product Viterion TeleHealth Monitor Model Number V500; Product Codes 08832984 (US) and 02080468 (UK) - Physiological patient monitor (without arrhythmia detection or alarms).

Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.
Code Information All units are affected. Serial Numbers A3303HA000201, A3303HA000202, A3303HA000203, A3303HA000204, A3303HA000205, A3304HA000206, A3304HA000207, A3304HA000208, A3304HA000209, A3304HA000210, A3305HA000211, A3305HA000212, A3305HA000213, A3305HA000214, A3305HA000215, A3306HA000216, A3306HA000217, A3306HA000218, A3306HA000219, A3306HA000220, A3310HA000221, A3310HA000222, A3310HA000223, A3310HA000224, A3310HA000225, A3404HA000226, A3404HA000227, A3404HA000228, A3404HA000229, A3404HA000230, A3404HA000231, A3404HA000232, A3404HA000233, A3404HA000234, A3404HA000235, A3404HA000236, A3404HA000237, A3404HA000238, A3404HA000239, A3404HA000240, A3404HA000241, A3404HA000242, A3404HA000243, A3404HA000244, A3404HA000245, A3404HA000246, A3404HA000247, A3404HA000248, A3404HA000249, A3404HA000250, A3602HA000252, A3602HA000253, A3602HA000254, A3602HA000255, A3602HA000256, A3602HA000257, A3602HA000258, A3602HA000259, A3602HA000260, A3602HA000261, A3602HA000262, A3602HA000263, A3602HA000264, A3602HA000265, A3602HA000266, A3701HA000267, A3701HA000268, A3701HA000269, A3701HA000270, A3701HA000271, A3701HA000272, A3701HA000273, A3701HA000274, A3701HA000275, A3701HA000276, A3701HA000277, A3701HA000278, A3701HA000279, A3701HA000280, A3701HA000281, A3701HA000282, A3701HA000283, A3701HA000284, A3701HA000285, A3701HA000286, A3701HA000287, A3701HA000288, A3701HA000289, A3701HA000290, A3701HA000291, A3818HA000292, A3818HA000293, A3818HA000294, A3818HA000295, A3818HA000296, A3818HA000297, A3818HA000298, A3818HA000299, A3818HA000300, A3818HA000301, A3818HA000302, A3818HA000303, A3818HA000304, A3818HA000305, A3818HA000306, A3818HA000307, A3818HA000308, A3818HA000309, A3818HA000310, A3818HA000311, A3818HA000312, A3818HA000313, A3818HA000314, A3818HA000315, A3818HA000316, A3905HA000317, A3905HA000318, A3905HA000319, A3905HA000320, A3905HA000321, A3905HA000322, A3905HA000323, A3905HA000324, A3905HA000325, A3905HA000326, A3905HA000327, A3905HA000328, A3905HA000329, A3905HA000330, A3905HA000331, A3905HA000332, A3905HA000333, A3905HA000334, A3905HA000335, A3905HA000336, A3905HA000337, A3905HA000338, A3905HA000339, A3905HA000340, A3905HA000341, A3D01HA000342, A3D01HA000343, A3D01HA000344, A3D01HA000345, A3D01HA000346, A3D01HA000347, A3D01HA000348, A3D01HA000349, A3D01HA000350, A3D01HA000351, A3D01HA000352, A3D01HA000353, A3D01HA000354, A3D01HA000355, A3D01HA000356, A3D01HA000357, A3D01HA000358, A3D01HA000359, A3D01HA000360, A3D01HA000361, A3D01HA000362, A3D01HA000363, A3D01HA000364, A3D01HA000365, A3D01HA000366, A3D01HA000367, A3D01HA000368, A3D01HA000369, A3D01HA000370, A3D01HA000371, A3D01HA000372, A3D01HA000373, A3D01HA000374, A3D01HA000375, A3D01HA000376, A3D01HA000377, A3D01HA000378, A3D01HA000379, A3D01HA000380, A3D01HA000381, A3D01HA000382, A3D01HA000383, A3D01HA000384, A3D01HA000385, A3D01HA000386, A3D01HA000387, A3D01HA000388, A3D01HA000389, A3D01HA000390, A4113HA000391, A4113HA000392, A4113HA000393, A4113HA000394, A4113HA000395, A4113HA000396, A4113HA000397, A4113HA000398, A4113HA000399, A4113HA000400, A4113HA000401, A4113HA000402, A4113HA000403, A4113HA000404, A4113HA000405, A4113HA000406, A4113HA000407, A4113HA000408, A4113HA000409, A4113HA000410, A4113HA000411, A4113HA000412, A4113HA000413, A4113HA000414, A4113HA000415, A4113HA000416, A4113HA000417, A4113HA000418, A4113HA000419, A4113HA000420, A4113HA000421, A4113HA000422, A4113HA000423, A4113HA000424, A4113HA000425, A4113HA000426, A4113HA000427, A4113HA000428, A4113HA000429, A4113HA000430, A4113HA000431, A4113HA000432, A4113HA000433, A4113HA000434, A4113HA000435, A4113HA000436, A4113HA000437, A4113HA000438, A4113HA000439, A4113HA000440, A4113HA000441, A4526MA000442, A4526MA000443, A4526MA000444, A4526MA000446, A4712MA000445, A4712MA000447, A4712MA000448, A4712MA000449, A4712MA000450, A4712MA000451, A4712MA000452, A4712MA000453, A4712MA000454, A4712MA000455, A4712MA000456, A4712MA000457, A4712MA000458, A4712MA000459, A4712MA000460, A4712MA000461, A4712MA000462, A4712MA000463, A4712MA000464, A4712MA000465,
Recalling Firm/
Viterion TeleHealthcare Llc
555 White Plains Rd
Tarrytown NY 10591-5101
For Additional Information Contact Rick Kates
Manufacturer Reason
for Recall
Viterion telehealth monitors do not transmit "HI" (above the meter's measurable range) and "LO" (below the meter's measurable range) blood glucose readings from Bayer's Contour Elite XL blood glucose meters, or from Roche's Accu-Chek Advantage 03 and 04 meters to healthcare professionals.
FDA Determined
Cause 2
Software design
Action Bayer Healthcare sent "IMPORTANT RECALL INFORMATION" to all affected customers.The letter identified the product, problem, and actions to be taken by the customers. Contact Viterion Support at 1-800-866-0133 option 1 for questions relating to this issue.
Quantity in Commerce Domestic - 296 units, Foreign - 73 units
Distribution Worldwide Distribution-USA (nationwide) and the United Kingdom.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MWI and Original Applicant = MATSUSHITA ELECTRIC INDUSTRIAL CO., LTD.