Class 2 Device Recall Viterion 100 TeleHealth Monitor

• Date Initiated by Firm: May 25, 2011
• Date Posted: February 15, 2012
• Recall Status: Terminated on July 02, 2018
• Recall Number: Z-1036-2012
• Recall Event ID: 60946
• Product Classification: Monitor,physiological,patient(without arrhythmia detection or alarms) - Product Code MWI
• Product: Viterion 100-BGM TeleHealth Monitor, Model No. 09377512, Product Code/Part No. 81842478, Bayer HealthCare LLC 555 White Plains Road, Tarrytown, NY 10591-5097 USA --- Manufactured in Japan for Bayer HealthCare LLC -- Common Name: Viterion100 TeleHealth Monitor -- Classification Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) [ref. 21CFR 870.2300]; ; Product Usage:; The Viterion 100 TeleHealth Monitor and related Data Server are physiological monitoring systems. The systems collect, accumulate and periodically transmit patient vital signs and other physiological data from a patient who may be remote from the healthcare practitioner to the practitioner, and provides communication between the patient and the practitioner. The physiological monitoring instrument, selected by the healthcare practitioner, operates in conjunction with the Patient Terminal located in the patients home, a hospital room, nursing home, or other healthcare facility. The Patient Terminal connects to the server via a conventional or cellular telephone line. The system is not a real-time monitoring system, and there is no requirement that a health care professional review the information at any specific interval or provide immediate feedback to patients. Rather, the system is intended to aid the physicians longer term management of patients. Patients are expected to take the same short term actions in response to physiological data as they ordinarily would in the absence of the Tele Health Monitor.
• Code Information: Serial Numbers: 22031, 22036, 22041, 22046, 22049, 22051, 22207, 22232, 22233, 22234, 22236, 22237, 22238, 22239, 22240, 22241, 22243, 22244, 22246, 22247, 22248, 22249, 22251, 22252, 23292, 23297, 23298, 23299, 23302, 23303, 23304, 23309, 23310, 23311, 23314, 23315, 23316, 23319, 23320, 23321, 23325, 23326, 23329, 23330, 23331, 23682, 23683, 23684, 23687, 23688, 23689, 23692, 23693, 23697, 23698, 23699, 23702, 23703, 23704, 23707, 23708, 23709, 23712, 23713, 23714, 23717, 23718, 23719, 23722, 23723, 23724, 23728, 23729, 19197, 19206, 19773, 22508, 25499, 16976, 16983, 16984, 16989, 16974, 16975, 16982, 16985, 16986, 16987, 16988, 16990, 17685, 18837, 18842, 19201, 19208, 19211, 19220, 19221, 19225, 19226, 19229, 19231, 19265, 19600, 19601, 19605, 19615, 19616, 19620, 19625, 19626, 19635, 19641, 19784, 21007, 21010, 21011, 21322, 21329, 21335, 21340, 21343, 21378, 21395, 22050, 23197, 23198, 23199, 23204, 23214, 23293, 23294, 24484, 24485, 24487, 24489, 24494, 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• Recalling Firm/ Manufacturer: Viterion TeleHealthcare Llc; 555 White Plains Rd; Tarrytown NY 10591-5101
• For Additional Information Contact: Rick Kates; 914-333-6610
• Manufacturer Reason for Recall: Software defect; Specifically, blood glucose (BG) results from the Roche Aviva meter that are tagged by the user with either the meter hypoglycemic or general "asterisk" flags (*) will not be automatically transmitted through the Viterion 100-BGM monitor containing software version 3.2.0 or displayed to the health care provider through the data server.
• FDA Determined Cause: Software design
• Action: On May 12, 2011, Bayer Healthcare (aka Viterion) telephoned their consignees regarding the issue with the Viterion 100-BGM and Roche ACCU-CHEK Aviva Flagged Data and followed-up with a letter (dated May 27, 2011) via e-mail. The letter notified customers of the issues and provided information on how to work around the problems. The letter provided the following recommendations: (1) The information concerning the general asterisk (*) flag be communicated within their organization as an amendment to the current patient Safety Alert Notice that was distributed and posted in April 2011. (2) For patients who need to use the Aviva Hypo and/or the asterisk flag, please assign Manual Data Entry for blood glucose on the V100-BGM. The letter informs customers that Bayer has completed the software development to rectify the aforementioned data transmission issue and will upgrade all affected products. Bayer request that customers confirm their receipt of this memo in writing and for any questions concerning this situation, contact Thuy Nguyen, Manager Quality Assurance and Regulatory Affairs at 914-333-6821.
• Quantity in Commerce: 3905 units domestically
• Distribution: (USA) Nationwide Distribution
• 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.