Viterion TeleHealthcare Llc: Medical Device Recall in 2013 - (Recall #: Z-0821-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 15, 2012

Date Posted: February 20, 2013

Recall Number: Z-0821-2013

Event ID: 64111

Reason for Recall:

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.

Status: Terminated

Product Quantity: Domestic - 7698 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated