DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor: Produc...
FDA Device Recall #Z-1586-2013 — Class II — April 15, 2013
Recall Summary
| Recall Number | Z-1586-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 15, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medrad Inc |
| Location | Indianola, PA |
| Product Type | Devices |
| Quantity | 1,066 |
Product Description
DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor: Product Usage: Monitor, Physiological, Patient
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.
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.
Lot / Code Information
Catalog numbers 3011992, 3011992W, 3011993, 3011993W, 3011994, 3011994W, 3011996, 3011996W, 3014268 and 3014268W.
Other Recalls from Medrad Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0870-2013 | Class II | MEDRAD Hand Controller Sheath, Catalog number A... | Nov 5, 2012 |
| Z-0598-2013 | Class II | Medrad(R) Continuum MR Infusion System Primary ... | Apr 18, 2012 |
| Z-0601-2013 | Class II | Medrad(R) Continuum MR Infusion System Primary ... | Apr 18, 2012 |
| Z-0596-2013 | Class II | Medrad(R) Continuum MR Infusion System Standard... | Apr 18, 2012 |
| Z-0599-2013 | Class II | Medrad(R) Continuum MR Infusion System Primary ... | Apr 18, 2012 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.