Pre-wired ECG Electrode Set Fails Defibrillation Voltage Safety Standard
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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a risk-of-harm product with no reported injuries or illnesses. The device's failure to withstand required voltage levels could compromise defibrillation effectiveness in life-critical cardiac emergencies.
Plain-English summary
Graphic Controls Acquisition Corporation is recalling the CLARAVUE Pre-wired Electrode - IP SET 12 RT ADULT-US (Model 32028779), a cardiac monitoring device used for ECG measurement. Approximately 8,265 units were distributed nationwide.
The device does not comply with the ANSI/AAMI EC53:2013/(R)2020 standard for ECG trunk cables and patient leadwires. It fails to withstand 5,000 volts direct current without breakdown when used with a defibrillator operating at or above its maximum voltage threshold. As a result, the device delivers an inefficient electrical charge.
This electrical performance failure may result in ineffective defibrillation during emergency cardiac care. The device has been distributed to healthcare facilities in Arkansas, California, Colorado, Florida, Indiana, Kansas, Massachusetts, Minnesota, New York, Oklahoma, and Vermont.
The recalled product
- Product
- CLARAVUE Pre-wired Electrode - IP SET 12 RT ADULT-US Model: 32028779 50602-US
- Manufacturer
- Graphic Controls Acquisition Corporation
- Hazard
- electrical-hazard
- defibrillation-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots UDI: 03700506307326
Distribution
Distributed nationwide across the United States.
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