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

FDA device recall Z-0810-2014 · posted 2014-01-23 · Terminated

Recall details

Recalling firm

Medrad Mr Inc

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

MWI

Quantity affected

922 units

Distribution

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

Date initiated

2013-11-21

Date posted

2014-01-23

Date terminated

2015-03-30

Location

Warrendale, PA

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