Reported Feb 20, 2013 · Terminated
Viterion TeleHealth Monitor Model Number V100-BGM, Product Code 81842478 (US) -- Physiological patient monitor (without…
Viterion TeleHealthcare LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Viterion TeleHealthcare Llc · 555 White Plains Rd · Tarrytown, NY · 10591-5101
Is this the product you have?
- 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.
- Lot codes and dates
- All units are affected. List of affected serial numbers were provided as Excel spreadsheet due to the large volume.
- Amount recalled
- Domestic - 7698 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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