Viterion TeleHealth Monitor Model Number V100-BGM — Class II medical device recall Z-0821-2013
Terminated recall by Viterion TeleHealthcare Llc, reported 2013-02-20, distributed nationwide. Viterion telehealth monitors do not transmit "HI" (above the meter's measurable range) and "LO" (below the met
| Recall number | Z-0821-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Viterion TeleHealthcare Llc, Tarrytown, NY, United States |
| Recall initiated | 2012-11-15 |
| Classified | 2013-02-14 |
| Reported by FDA | 2013-02-20 |
| Terminated | 2017-02-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | GB |
| Quantity | 7,698 units |
| Model numbers | V100-BGM |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0821-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.