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U.S. Department of Health and Human Services

Class 2 Device Recall DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor

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  Class 2 Device Recall DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor see related information
Date Initiated by Firm April 15, 2013
Date Posted June 25, 2013
Recall Status1 Terminated 3 on April 03, 2014
Recall Number Z-1586-2013
Recall Event ID 65411
510(K)Number K042569  
Product Classification Monitor,physiological,patient(without arrhythmia detection or alarms) - Product Code MWI
Product DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor:

Product Usage:
Monitor, Physiological, Patient
Code Information Catalog numbers 3011992, 3011992W, 3011993, 3011993W, 3011994, 3011994W, 3011996, 3011996W, 3014268 and 3014268W.
Recalling Firm/
Manufacturer		 Medrad Inc
1 Medrad Dr
Indianola PA 15051-9759
For Additional Information Contact Customer Support Team
877-229-3767
Manufacturer Reason
for Recall		 The firm is recalling these power cables due to a latent design reliability issue and the potential for shorting which can result in heating/melting of the cable jacket.
FDA Determined
Cause 2		 Device Design
Action Medrad Inc sent an Urgent Medical Device Component Recall letter dated April 15, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter states that replacement products will be available in June and shipped in the coming months along with additional instructions for returning the affected product. Customers were instructed to complete the enclosed recall response form and fax it back to Bayer at 412-406-0942. For questions contact customer support team at 1-877-229-3767 and select option 2.
Quantity in Commerce 1,066
Distribution Worldwide Distribution - US Nationwide including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and the countries of: AE, AU, AZ, BN, BR, CA, CH, CL, CO, DE, DK, DO, DZ, EG, ES, FR, GB, HK, HN, HR, HU, IN, IT, JO, JP, KR, LB, MU, MX, MY, NL, PH, PS, SA, SG, TH, TR, TW, UY, VE, and ZA.
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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