GE Healthcare recalls specific CARESCAPE Patient Data Modules used with certain monitors due to risk of false flat line ECG alerts when AEDs are used.
The CARESCAPE Patient Data Module (PDM) is used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro. If Pace detection is turned ON, on the monitor, and if an Automated External Defibrillator (AED) is used to perform defibrillation, the low frequency signals deployed by the AED, cause the PDM to issue a false flat line ECG waveform and alarm Asystole to be displayed on the monitor.
GE Healthcare is recalling specific models of CARESCAPE Patient Data Modules that can display false 'asystole' alarms when an Automated External Defibrillator (AED) is used during defibrillation. This could lead to incorrect medical responses if the alarm is triggered.
When the Patient Data Module (PDM) is set to 'Pace detection' mode and an AED delivers a shock, the low-frequency signals from the AED cause the PDM to incorrectly show a flat line ECG waveform and trigger an 'asystole' alarm. This could lead to unnecessary emergency responses or delayed treatment.
Healthcare providers using the recalled Patient Data Modules with specific monitors are at risk. Patients receiving care with these devices may experience delayed or incorrect medical responses if the false alarm occurs.
Check if your PDM has model numbers listed in the provided list (e.g., 2042084-001) or software versions 2.6 or 2.7. The device is used with specific GE monitors like CARESCAPE B450/B650/B850, SOLAR 8000M/I, and Transport Pro.
Identify your PDM model number by checking the device label or documentation. The recalled models include specific numbers listed in the record.
Ensure your PDM software version is not 2.6 or 2.7, as these versions are affected by the issue.
The PDM can display a false 'asystole' alarm when an AED is used during defibrillation, which may lead to incorrect medical responses.
Check your PDM model number and software version. If it matches the recalled models, contact GE Healthcare for guidance.
The recall record does not specify a fix or remedy; users are advised to check their device and contact GE Healthcare.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2424-2020 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-2424-2020 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
