Device product
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.
Z-0810-2014
Product summary
- Firm
- Medrad Mr Inc
- Event
- Event 66996
- Status
- Terminated
- Classification
- Class II
- Quantity
- 922 units
- Official record key
device-enforcement:Z-0810-2014
Official wording
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.
Code information: P/N 301641, Catalog #s 3011992, 3011992W, 3011993, 3011993W, 3011994, 3011994W, 3011996, 3011996W, 3014268, 3014268W, with multiple serial numbers.
Distribution pattern: Worldwide Distribution: US (nationwide) and Internationally to: Canada.
Derived failure modes
-
Unknown
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.