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U.S. Department of Health and Human Services

Class 2 Device Recall Viterion V100BGM Telehealth Monitors

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 Class 2 Recall
Viterion V100BGM Telehealth Monitors
see related information
Date Posted February 14, 2013
Recall Status1 Open
Recall Number Z-0821-2013
Recall Event ID 64111
Premarket Notification
510(K) Number
K030419 
Product Classification Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms) - Product Code MWI
Product Viterion TeleHealth Monitor Model Number V100-BGM, Product Code 81842478 (US) -- 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, New York 10591-5101
Consumer Instructions No consumer action necessary
For Additional Information Contact Rick 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
DESIGN: 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 - 7698 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 = VITERION TELEHEALTHCARE LLC
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