FDAFDA · Food and drugs·Recall number Z-0821-2013
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.
Published February 20, 2013 · Recall initiated: November 15, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Viterion TeleHealthcare Llc
- Distributor
- Worldwide Distribution-USA (nationwide) and the United Kingdom.
- Lot
- All units are affected. List of affected serial numbers were provided as Excel spreadsheet due to the large volume.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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