CLARAVUE Pre-wired Electrode - IP SET 12 RT ADULT-US Model: 32028779 50602-US
Check against the official notice below — it lists the full affected range.
Graphic Controls Acquisition Corporation is recalling the CLARAVUE Pre-wired Electrode - IP SET 12 RT ADULT-US (Model: 32028779 50602-US) because the device does not meet the required electrical safety standards. The Instructions for Use claim compliance with ANSI/AAMI EC53:2013/(R)2020 standards, which require the device to withstand 5,000 volts of direct current when used with a defibrillator without breaking down. However, the CLARAVUE device fails to meet this specification and delivers an inefficient electrical charge, which may result in ineffective defibrillation.
The recall affects 8,265 units distributed nationwide across Arkansas, California, Colorado, Florida, Indiana, Kansas, Massachusetts, Minnesota, New York, Oklahoma, and Vermont. All lots are included in the recall, identified by UDI: 03700506307326. The recall source does not specify a remedy or recommended action for affected consumers.
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: 8265 units Lot/code info: All lots UDI: 03700506307326
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.