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Recall Observatory FDA recall evidence

Device 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.

Z-0821-2013

November 15, 2012

Class II

Product summary

Firm
Viterion TeleHealthcare Llc
Event
Event 64111
Status
Terminated
Classification
Class II
Quantity
Domestic - 7698 units
Official record key
device-enforcement:Z-0821-2013

Official wording

Reason: 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.

Code information: All units are affected. List of affected serial numbers were provided as Excel spreadsheet due to the large volume.

Distribution pattern: Worldwide Distribution-USA (nationwide) and the United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.