Viterion TeleHealth Monitor Model Number V500; Product Codes 08832984 (US) and 02080468 (UK) - Physiological patient mon
FDA device recall Z-0822-2013 · posted 2013-02-14 · Terminated
Recall details
- Recalling firm
- Viterion TeleHealthcare Llc
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MWI
- Quantity affected
- Domestic - 296 units, Foreign - 73 units
- Distribution
- Worldwide Distribution-USA (nationwide) and the United Kingdom.
- Date initiated
- 2012-11-15
- Date posted
- 2013-02-14
- Date terminated
- 2017-02-16
- Location
- Tarrytown, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PANASONIC TELE-HOMECARE SYSTEM (K004050) | Matsushita Electric Industrial Co., Ltd. | 2001-03-15 |