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U.S. Department of Health and Human Services

Class 2 Device Recall Medrad Veris MR Monitors

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  Class 2 Device Recall Medrad Veris MR Monitors see related information
Date Initiated by Firm November 21, 2013
Date Posted January 23, 2014
Recall Status1 Terminated 3 on March 30, 2015
Recall Number Z-0810-2014
Recall Event ID 66996
510(K)Number K042569  
Product Classification Monitor,physiological,patient(without arrhythmia detection or alarms) - Product Code MWI
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.
Code Information P/N 301641, Catalog #s 3011992, 3011992W, 3011993, 3011993W, 3011994, 3011994W, 3011996, 3011996W, 3014268, 3014268W, with multiple serial numbers.
Recalling Firm/
Manufacturer		 Medrad Mr Inc
100 Global View Dr
Warrendale PA 15086-7601
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MWI and Original Applicant = CRITICARE SYSTEMS, INC.
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