Recall Z-1036-2012 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Viterion TeleHealthcare Llc
Viterion 100-BGM TeleHealth Monitor, Model No. 09377512, Product Code/Part No. 81842478, Bayer HealthCare LLC 555 White Plains Road, Tarrytown, NY 10591-5097 USA --- Manufactured in Japan for Bayer HealthCare LLC -- Common Name: Viterion100 TeleHealth Monitor -- Classification Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) [ref. 21CFR 870.2300] Product Usage: The
| Date | Feb 15, 2012 (initiated May 25, 2011) |
| Status | Terminated |
| Reason | Software defect; Specifically, blood glucose (BG) results from the Roche Aviva meter that are tagged by the user with either the meter hypoglycemic or general "asterisk" flags (*) will not be automatically transmitted through the Viterion 100-BGM monitor containing software version 3.2.0 or displayed to the health care provider through the data server. |
| Root cause | Software design |
| Action | On May 12, 2011, Bayer Healthcare (aka Viterion) telephoned their consignees regarding the issue with the Viterion 100-BGM and Roche ACCU-CHEK Aviva Flagged Data and followed-up with a letter (dated May 27, 2011) via e-mail. The letter notified customers of the issues and provided information on how to work around the problems. The letter provided the following recommendations: (1) The information concerning the general asterisk (*) flag be communicated within their organization as an amendment to the current patient Safety Alert Notice that was distributed and posted in April 2011. (2) For |
| Quantity | 3905 units domestically |
| Distribution | (USA) Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.