Recall Z-0822-2013 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Viterion TeleHealthcare Llc
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.
| Date | Feb 14, 2013 (initiated Nov 15, 2012) |
| Status | Terminated |
| Reason | 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 | 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 | Domestic - 296 units, Foreign - 73 units |
| Distribution | Worldwide Distribution-USA (nationwide) and the United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K004050 | PANASONIC TELE-HOMECARE SYSTEM Matsushita Electric Industrial Co., Ltd., Mar 15, 2001 |