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Recall Observatory FDA recall evidence

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

November 21, 2013

Class II

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

    reason.no_named_rule · v1.0.0

    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.