Use caution Medical device recall · FDA · Published May 18, 2020

GE Healthcare recalls CARESCAPE Patient Data Module with AED false flat line risk

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2424-2020Medical device GE Healthcare ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmGE Healthcare, LLC3000 N Grandview Blvd · Waukesha, WI 53188-1615

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/65127-ge-healthcare-recalls-carescape-patient-data-module-with-aed-false.

Source Summary by GovInfoNow · govinfonow.com/recall/65127-ge-healthcare-recalls-carescape-patient-data-module-with-aed-false · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2424-2020

Cite this page

“GE Healthcare recalls CARESCAPE Patient Data Module with AED false flat line risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65127-ge-healthcare-recalls-carescape-patient-data-module-with-aed-false. Based on FDA recall #Z-2424-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2424-2020%22&limit=1).

The FDA announced on May 18, 2020, that GE Healthcare LLC is recalling CARESCAPE Patient Data Modules (PDM) used with specific monitors due to a hazard involving false flat line ECG waveforms. The recall affects approximately 89,109 units distributed worldwide.

How to tell if you have it

Brand: GE Healthcare
Product: CARESCAPE Patient Data Module (PDM)
Compatible Monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I, Transport Pro
Model Numbers: 2042084-001, 2094504-001, and all model numbers containing software versions 2.6 or 2.7 (including suffixes such as -046050, -208621, etc.)
Quantity: 89,109 units

The hazard

If Pace detection is turned ON on the monitor and an Automated External Defibrillator (AED) is used for defibrillation, low frequency signals from the AED cause the PDM to issue a false flat line ECG waveform. This results in an Asystole alarm being displayed on the monitor.

Context

GovInfoNow's records show GE Healthcare LLC has conducted 97 other recalls since October 4, 2017. Recent brand recalls include SIGNA Premier MRI Scanners with steel fittings (February 27, 2026), Centricity Universal Viewer inaccurate measurements (July 15, 2022), and SIGNA Premier acoustic noise risks (June 24, 2022). Other recent recalls of similar products include GE Medical Systems Allia IGS 3 Pulse X-Ray System electrical shock risk (April 20, 2026), CARESCAPE Telemetry Server V5 monitoring loss (April 24, 2026), and Portrait Core Services Software patient monitoring risk (July 20, 2026).

How to tell if you have this one

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.

Brand
GE Healthcare
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Model
Identify your PDM model number by checking the device label or documentation. The recalled models include specific numbers listed in the record.
Verify Software Version
Ensure your PDM software version is not 2.6 or 2.7, as these versions are affected by the issue.

How this recall unfolded

Recall timeline

FDA published this recall 44 days after the firm started it.

May 18, 2020Firm started the recall
Jun 23, 2020FDA classified it Class II
Jul 1, 2020Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/65127-ge-healthcare-recalls-carescape-patient-data-module-with-aed-false">GE Healthcare recalls CARESCAPE Patient Data Module with AED false flat line risk (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-2424-2020 (May 18, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2424-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.