RecallRadar

FDA Device recall Z-0810-2014

Medrad Veris MR Monitor units The system is intended to monitor physiological parameters of patients within any healthcare environment

On 2014-01-29 the FDA classified a Class II recall of Medrad Veris MR Monitor units The system is intended to monitor physiological parameters of patients within any healthcare environment by Medrad Mr, citing 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 o….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0810-2014
ClassificationClass II
Statusterminated
Initiated2013-11-21
Published2014-01-29
Last updated2026-09-13 11:53 UTC
CompanyMedrad Mr
DistributionUS

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.

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.

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0810-2014%22

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