Z-0820-2013Class II

Viterion TeleHealth Monitor Model Number V100, Product Codes 09377512 (US) and 04480218 (UK). Physiological...

Name: Z-0820-2013 Viterion TeleHealth Monitor Model Number V100, Product Codes 09377512 (US) and 04480218 (UK). Physiological...
Creator: Viterion TeleHealthcare Llc
Published: 2012-11-15
License: https://open.fda.gov/license/

Viterion Telehealthcare, LLC / initiated 2012-11-15 / Terminated / root cause: software

FDA source

Viterion TeleHealthcare Llc began a recall of Viterion TeleHealth Monitor Model Number V100, Product Codes 09377512 (US) and 04480218 (UK). Physiological patient monitor (without arrhythmia detection or... on 2012-11-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0820-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-15
Posted: 2013-02-14
Terminated: 2017-02-16
Recalling firm: Viterion Telehealthcare, LLC
Product: Viterion TeleHealth Monitor Model Number V100, Product Codes 09377512 (US) and 04480218 (UK). Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.
Product code: MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
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.
Root cause tag: software
FDA root cause: Software design
Action: Bayer Healthcare sent "IMPORTANT RECALL INFORMATION" to all affected customers.The letter identified the product, problem, and actions to be taken by the customers. Contact Viterion Support at 1-800-866-0133 option 1 for questions relating to this issue.
Quantity in commerce: Domestic: 19,106 units; Foreign: 267 units
Distribution: Worldwide Distribution-USA (nationwide) and the United Kingdom.
Product codes and lots: All units are affected. List of affected serial numbers were provided as Excel spreadsheet due to the large volume.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0820-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0820-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-20	2013-02-14
Z-0821-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-20	2013-02-14
Z-0822-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-20	2013-02-14

Product code MWI

K030419Class IIViterion 100 Telehealth MonitorViterion Telehealthcare, LLC / cleared 2003-11-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)