CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Model: 32028777 50600 US
Check against the official notice below — it lists the full affected range.
The CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US (Model 32028777 50600) is being recalled because it does not meet the electrical safety requirements specified in the ANSI/AAMI EC53:2013/(R)2020 standard. The device fails to withstand a 5,000 volt direct current application when used with a defibrillator operating above its maximum threshold voltage. This failure means the device delivers an inefficient electrical charge that may result in ineffective defibrillation. A total of 560 units have been distributed nationwide across Arkansas, California, Colorado, Florida, Indiana, Kansas, Massachusetts, Minnesota, New York, Oklahoma, and Vermont.
The recall affects all lots of the product, which can be identified by UDI 03700506307340. The source document does not specify a remedy or what affected consumers should do.
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: 560 units Lot/code info: All lots UDI: 03700506307340
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.