Recall Z-1586-2013 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Medrad Inc
DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor: Product Usage: Monitor, Physiological, Patient
| Date | Jun 25, 2013 (initiated Apr 15, 2013) |
| Status | Terminated |
| 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. |
| 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 | 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, B |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042569 | 8600 VITAL SIGNS MONITOR Criticare Systems, Inc., Sep 29, 2004 |