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Class 2 Device Recall DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor |
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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
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Product Classification |
Monitor,physiological,patient(without arrhythmia detection or alarms) - Product Code MWI
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Product |
DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor:
Product Usage: Monitor, Physiological, Patient
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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
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For Additional Information Contact |
Customer Support Team 877-229-3767
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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.
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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
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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.
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510(K) Database |
510(K)s with Product Code = MWI and Original Applicant = CRITICARE SYSTEMS, INC.
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