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U.S. Department of Health and Human Services

Class 2 Device Recall Viterion V100 Telehealth Monitors

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 Class 2 Device Recall Viterion V100 Telehealth Monitorssee related information
Date Initiated by FirmNovember 15, 2012
Date PostedFebruary 14, 2013
Recall Status1 Terminated 3 on February 16, 2017
Recall NumberZ-0820-2013
Recall Event ID 64111
510(K)NumberK030419 
Product Classification Monitor,physiological,patient(without arrhythmia detection or alarms) - Product Code MWI
ProductViterion TeleHealth Monitor Model Number V100, Product Codes 09377512 (US) and 04480218 (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. List of affected serial numbers were provided as Excel spreadsheet due to the large volume.
Recalling Firm/
Manufacturer		 Viterion TeleHealthcare Llc
555 White Plains Rd
Tarrytown NY 10591-5101
For Additional Information ContactRick Kates
914-333-6253
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
ActionBayer 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 CommerceDomestic: 19,106 units; Foreign: 267 units
DistributionWorldwide Distribution-USA (nationwide) and the United Kingdom.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MWI
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