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Medrad Veris MR Monitor units The system is intended to monitor physiological parameters of p...

FDA Recall #Z-0810-2014 — Class II — November 21, 2013

Recall #Z-0810-2014 Date: November 21, 2013 Classification: Class II Status: Terminated

Product Description

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.

Reason for Recall

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.

Recalling Firm

Medrad Mr Inc — Warrendale, PA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

922 units

Distribution

Worldwide Distribution: US (nationwide) and Internationally to: Canada.

Code Information

P/N 301641, Catalog #s 3011992, 3011992W, 3011993, 3011993W, 3011994, 3011994W, 3011996, 3011996W, 3014268, 3014268W, with multiple serial numbers.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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