CLARAVUE Pre-wired Electrode - IP SET 6V RT ADULT-US Model: 32028780 50603-US
Check against the official notice below — it lists the full affected range.
Graphic Controls Acquisition Corporation has recalled the CLARAVUE Pre-wired Electrode - IP SET 6V RT ADULT-US (Model: 32028780 50603-US) due to a safety defect. The device's instructions indicate it complies with the ANSI/AAMI EC53:2013/(R)2020 standard for ECG trunk cables and patient leadwires, which requires the device to withstand 5,000 volts of direct current when used with a defibrillator operating above its maximum threshold without electrical breakdown. However, the CLARAVUE does not meet this specification and delivers an inefficient electrical charge, which may result in ineffective defibrillation.
The recalled devices were distributed nationwide across Arkansas, California, Colorado, Florida, Indiana, Kansas, Massachusetts, Minnesota, New York, Oklahoma, and Vermont, affecting all lots with UDI 03700506307319. The recall record does not specify a remedy or the actions affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: US Nationwide distribution in the States of AR, CA, CO, FL, IN, KS, MA, MN, NY, OK, VT. Quantity: N/A Lot/code info: All lots UDI: 03700506307319
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.