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

FDA device recall Z-1586-2013 · posted 2013-06-25 · Terminated

Recall details

Recalling firm

Medrad Inc

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

MWI

Quantity affected

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, O

Date initiated

2013-04-15

Date posted

2013-06-25

Date terminated

2014-04-03

Location

Indianola, PA

Related 510(k) clearances