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Recall Observatory FDA recall evidence

Device product

DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor: Product Usage: Monitor, Physiological, Patient

Z-1586-2013

April 15, 2013

Class II

Product summary

Firm
Medrad Inc
Event
Event 65411
Status
Terminated
Classification
Class II
Quantity
1,066
Official record key
device-enforcement:Z-1586-2013

Official wording

Reason: 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.

Code information: Catalog numbers 3011992, 3011992W, 3011993, 3011993W, 3011994, 3011994W, 3011996, 3011996W, 3014268 and 3014268W.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.