Graphic Controls recalls CLARAVUE Pre-wired Electrode IP SET 6V RT ADULT-US Model 32028780 50603-US due to potential ineffective defibrillation when used with defibrillators.
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.
Graphic Controls is recalling CLARAVUE Pre-wired Electrode IP SET 6V RT ADULT-US models because they may not deliver an effective electrical charge during defibrillation. This could lead to ineffective treatment in emergency situations.
The device fails to meet ANSI/AAMI EC53:2013 standards for withstanding 5,000 V d.c. when used with defibrillators at high voltages. This results in inefficient electrical charge delivery, potentially causing ineffective defibrillation during cardiac emergencies.
Medical professionals using the CLARAVUE Pre-wired Electrode for defibrillation in emergency settings are most at risk. Patients receiving defibrillation with this device could face ineffective treatment.
Check for the model number 32028780 50603-US on the CLARAVUE Pre-wired Electrode. The device has a unique identifier (UDI) starting with 03700506307319.
Look for the model number 32028780 50603-US on the CLARAVUE Pre-wired Electrode.
Reach out to Graphic Controls for guidance on next steps if you have the recalled device.
The device may not deliver an effective electrical charge during defibrillation when used with defibrillators at high voltages, potentially leading to ineffective treatment.
The model number is 32028780 50603-US.
The recall record does not specify a remedy or fix.
We’ve drafted a message you can send Graphic Controls to request your refund or repair — edit it as you like.
Subject: Recall Z-0939-2022 — Graphic Controls Graphic Controls Hello, I own a Graphic Controls that is covered by recall Z-0939-2022 from Graphic Controls. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
