Z-1586-2013Class II

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

Name: Z-1586-2013 DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor
Creator: Medrad Inc
Published: 2013-04-15
License: https://open.fda.gov/license/

Medrad, Inc. / initiated 2013-04-15 / Terminated / root cause: design

FDA source

Medrad Inc began a recall of DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor: Product Usage: Monitor, Physiological, Patient on 2013-04-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1586-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-15
Posted: 2013-06-25
Terminated: 2014-04-03
Recalling firm: Medrad, Inc.
Product: DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor: Product Usage: Monitor, Physiological, Patient
Product code: MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
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.
Root cause tag: design
FDA root cause: 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.
Product codes and lots: Catalog numbers 3011992, 3011992W, 3011993, 3011993W, 3011994, 3011994W, 3011996, 3011996W, 3014268 and 3014268W.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1586-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1586-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-24

Product code MWI

K042569Class II8600 Vital Signs MonitorCriticare Systems, Inc. / cleared 2004-09-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)