Viterion TeleHealth Monitor Model Number V500; Product Codes 08832984 (US) and 02080468 (UK) - Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.

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 El…

Recall #: Z-0822-2013
Affected scope: Domestic - 296 units, Foreign - 73 units
Initiated: November 15, 2012

Compiled from official public sources by the publisher. · Updated September 2026

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Viterion TeleHealthcare Llc recalled Viterion TeleHealth Monitor Model Number V500; Product Codes 08832984 (US) and 02080468 (… - a moderate-severity action.

Viterion TeleHealth Monitor Model Number V500; Product Codes 08832984 (US) and 02080468 (… was recalled by Viterion TeleHealthcare Llc in February 20, 2013. Reason: Viterion telehealth monitors do not transmit "HI" (above the meter's measurable range) and "LO" (below the me…. Check the official notice for the remedy. Verify recall #Z-0822-2013 with the FDA Devices before acting.

The recall

Viterion TeleHealthcare Llc issued this moderate-severity FDA Devices recall-Viterion telehealth monitors do not transmit "HI" (above the meter's measurable range) and "LO" (below the me….

Moderate
severity level: Class II
classification: February 20, 2013
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0822-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

Viterion TeleHealth Monitor Model Number V500; Product Codes 08832984 (US) and 02080468 (UK) - 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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-0822-2013
Date reported	February 20, 2013
Date initiated	November 15, 2012
Recalling firm	Viterion TeleHealthcare Llc
Firm location	Tarrytown, NY
Affected scope	Domestic - 296 units, Foreign - 73 units
Distribution	Worldwide Distribution-USA (nationwide) and the United Kingdom.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-0822-2013) and product description against the item you own. Search the archive
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Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on February 20, 2013. Severity: Moderate. Recall number: Z-0822-2013.

Where was the recalled product distributed? ▼

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

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Similar severity · nearest report date

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This recall: FDA Devices, reported February 20, 2013. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026