Recall Z-0939-2022 ยท DRX Electrode, Electrocardiograph
Graphic Controls Acquisition Corporation
CLARAVUE Pre-wired Electrode - IP SET 6V RT ADULT-US Model: 32028780 50603-US
| Date | Mar 15, 2022 |
| Status | Terminated |
| Reason | Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an application of, 5,000 V d.c. when used with a defibrillator at a voltage above its maximum threshold, Claravue does not meet the specification and delivers an inefficient electrical charge which may result in an ineffective defibrillation. |
| Root cause | Device Design |
| Action | Graphic Controls (d/b/a Nissha Medical Technologies/Vermed/Biomedical Innovations) issued Urgent Field Correction letter via email on 3/4/22. Letter states reason for recall, health risk and action to take: Section 5.1.5 of the standard provides that trunk cables and patient leadwires may be permanently marked to indicate they are not defibrillation proof. Immediately examine your inventory and complete the provided form Claravue IP Set Correction Notice Acknowledgement Form and return to claravue@nisshamedical.com If you have product in inventory our team will arrange for it to be returned |
| Distribution | US Nationwide distribution in the States of AR, CA, CO, FL, IN, KS, MA, MN, NY, OK, VT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101685 | IP-SET Integral Process Sas, Jul 1, 2010 |