FDA (Devices) recall action 89810
The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Graphic Controls is recalling CLARAVUE Pre-wired Electrode sets because they fail to meet electrical safety specifications for defibrillators, potentially delivering inadequate charge during emergency treatment.
The CLARAVUE Pre-wired Electrode does not meet electrical safety standards for defibrillators. It may not deliver effective electrical charge during emergency defibrillation.
Graphic Controls' CLARAVUE Pre-wired Electrode set does not meet required electrical specifications for defibrillation use. The device fails to withstand 5,000 volts without breakdown, potentially resulting in ineffective defibrillation.
CLARAVUE Pre-wired ECG electrodes may not meet electrical safety standards for defibrillation, potentially delivering an ineffective electrical charge during emergency use. This is a Class II recall affecting devices nationwide.
Graphic Controls' CLARAVUE Pre-wired Electrode units fail to meet electrical safety specifications required for defibrillation. The device delivers an inefficient electrical charge and may result in ineffective defibrillation.
Graphic Controls' CLARAVUE pediatric electrode set fails electrical safety standards. The device may not deliver adequate charge during defibrillation, potentially rendering emergency treatment ineffective.