GE Healthcare recalls CardioLab/ComboLab Recording Systems with specific model numbers and lot codes due to potential failure in patient leakage current test, which could cause electrical shock if connected to other medical devices.
Potential for failure of the patient leakage current test. There is a potential that if another device with electrical connectivity (e.g., ablation device, ECG monitor) fails, then the CLab II Plus Amplifier will not prevent an electric current from completing a circuit, which could cause an electrical shock to a patient.
GE Healthcare is recalling certain CardioLab and ComboLab Recording Systems because they may fail to properly test patient leakage current. If these devices connect with other medical devices like ablation systems or ECG monitors, they could allow electrical shocks to patients.
The devices may fail to test patient leakage current properly. If another medical device with electrical connectivity fails, the CLab II Plus Amplifier might not prevent electrical current from completing a circuit, potentially causing a shock to the patient.
Medical professionals using the CardioLab/ComboLab Recording Systems for patient monitoring are most at risk. Patients using these systems with other medical devices could experience electrical shocks.
Check for model numbers 2088700-002 or 2088700-004 with specific lot numbers listed in the recall notice. These devices were sold with the mentioned lot codes between 2019 and 2020.
Identify if your CardioLab or ComboLab Recording System has model numbers 2088700-002 or 2088700-004 with the listed lot numbers.
If you have the recalled model with a listed lot number, stop using the device until you contact GE Healthcare for further instructions.
The devices may fail to properly test patient leakage current. If connected to other medical devices like ablation systems or ECG monitors, they could allow electrical shocks to patients.
Check for model numbers 2088700-002 or 2088700-004 with specific lot numbers listed in the recall notice.
The recall record does not specify a return process or replacement options.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0257-2020 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0257-2020 from GE Healthcare. 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.
