Z-0810-2014Class II

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

Name: Z-0810-2014 Medrad Veris MR Monitor units The system is intended to monitor physiological parameters of patients within...
Creator: Medrad Mr Inc
Published: 2013-11-21
License: https://open.fda.gov/license/

Medrad, Inc. / initiated 2013-11-21 / Terminated / root cause: design

FDA source

Medrad Mr Inc began a recall of Medrad Veris MR Monitor units The system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible... on 2013-11-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0810-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-21
Posted: 2014-01-23
Terminated: 2015-03-30
Recalling firm: Medrad, Inc.
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.
Product code: MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
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.
Root cause tag: design
FDA 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 number on your Medrad Veris unit(s). If this problem does occur, report this immediately to Bayer Customer Support at 1-877-229-3767. The customers were also instructed to fill out and fax back the attached form. Bayer Service Representative will then be in touch to schedule an appointment to come and replace your main board, at no cost to you. Bayer also informed their customers that based on the maximum inventory that can be produced by the supplier, they anticipate that this Field Corrective Action will take up to six months. If you have questions, please contact our Customer Support team at 1-877-229-3767.
Quantity in commerce: 922 units
Distribution: Worldwide Distribution: US (nationwide) and Internationally to: Canada.
Product codes and lots: P/N 301641, Catalog #s 3011992, 3011992W, 3011993, 3011993W, 3011994, 3011994W, 3011996, 3011996W, 3014268, 3014268W, with multiple serial numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0810-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0810-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-29	2014-01-23

Product code MWI

K042569Class II8600 Vital Signs MonitorCriticare Systems, Inc. / cleared 2004-09-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)