Recall Z-0810-2014 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Medrad Mr Inc
Medrad Veris MR Monitor units The system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional healthcare provider. Physiological data, gas monitoring, system alarms, and patient analysis will be available to the care provider from the monitor.
| Date | Jan 23, 2014 (initiated Nov 21, 2013) |
| Status | Terminated |
| Reason | The main board, P/N 301641, installed in some Medrad Veris MR Monitor units may be faulty and could lead to unexpected shutdown of the system while in use, resulting in the loss of vital signs information from the monitor. |
| Root cause | Device Design |
| Action | The firm, Bayer HealthCare, sent a "MEDICAL DEVICE FIELD CORRECTIVE ACTION" letter dated November 21, 2013 via certified mail to its users/customers. The letter described the product, problem and actions to be taken. The firm stated that, "You may choose to continue to use your Veris units but you MUST be vigilant about this potential issue. Should a shutdown occur, the system can be quickly restarted by pressing the POWER button. If this problem does occur, we ask that you report this immediately to Bayer Customer Support at 1-877-229-3767." The customers were instructed to verify the serial |
| Quantity | 922 units |
| Distribution | Worldwide Distribution: US (nationwide) and Internationally to: Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042569 | 8600 VITAL SIGNS MONITOR Criticare Systems, Inc., Sep 29, 2004 |