Company:Viterion Healthcare
Date of Enforcement Report 5/2/12
Class ll:
PRODUCT
Viterion 100-BGM TeleHealth Monitor, Model No. 09377512, Product Code/Part No. 81842478, 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. Recall # Z-1036-2012
REASON
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.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Viterion TeleHealthcare LLC, Tarrytown, NY, by telephone on May 12, 2011 and letter dated May 27, 2011.
Manufacturers: Matsushita Electric Industrial Co., Ltd. – Med. Sys. Div., Yokohama City, Kanagawa, Japan;
Viterion TeleHealthcare LLC, Tarrytown, NY, Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
3,905 units
DISTRIBUTION
Nationwide
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