Use caution Medical device recall · FDA · Published September 16, 2019

GE Healthcare CardioLab/ComboLab Systems Recall: Risk of Electrical Shock from Patient

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.

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

🇺🇸 FDA recall #Z-0257-2020Medical device GE Healthcare ›

Use caution until it’s fixed

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.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/67013-ge-healthcare-cardiolab-combolab-systems-recall-risk-of-electrical-shock.

Source Summary by GovInfoNow · govinfonow.com/recall/67013-ge-healthcare-cardiolab-combolab-systems-recall-risk-of-electrical-shock · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0257-2020

Cite this page

“GE Healthcare CardioLab/ComboLab Systems Recall: Risk of Electrical Shock from Patient.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67013-ge-healthcare-cardiolab-combolab-systems-recall-risk-of-electrical-shock. Based on FDA recall #Z-0257-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0257-2020%22&limit=1).

The FDA announced on 2019-09-16 that GE Healthcare LLC is recalling CardioLab/ComboLab Recording Systems due to a potential patient electrical shock hazard. Owners should contact the company for remedy details.

How to tell if you have it

Brand: GE Healthcare
Product: CardioLab/ComboLab Recording Systems
Model Number: 2088700-002
Lot Numbers (Model 2088700-002): RXJ19122006TA, RXJ19122002TA, RXJ19122010TA, RXJ19122001TA, RXJ19122005TA, RXJ19122007TA
Model Number: 2088700-004
Lot Numbers (Model 2088700-004): RXJ19204004TA, RXJ19154006TA, RXJ19224011TA, RXJ19224017TA, RXJ19224014TA, RXJ19154009TA, RXJ19154011TA, RXJ19154010TA, RXJ19154007TA, RXJ19194009TA, RXJ19154003TA, RXJ19224002TA, RXJ19224016TA, RXJ19204003TA, RXJ19154001TA, RXJ19194003TA, RXJ19224013TA, RXJ19194002TA, RXJ19194011TA, RXJ19204007TA, RXJ19154005TA, RXJ19204006TA, RXJ19194007TA, RXJ19194004TA, RXJ19154008TA, RXJ19204002TA, RXJ19224001TA, RXJ19194001TA, RXJ19224012TA, RXJ19194008TA, RXJ19194005TA, RXJ19154004TA, RXJ19194006TA, RXJ19224009TA, RXJ19204005TA, RXJ19194010TA, RXJ19154002TA

The hazard

The recall addresses the potential for failure of the patient leakage current test. If another device with electrical connectivity fails, the CLab II Plus Amplifier may not prevent an electric current from completing a circuit, which could cause an electrical shock to a patient.

Context

GovInfoNow's records show GE Healthcare LLC has 97 other recalls on record since 2017-10-04. Other recent recalls of similar products include GE Healthcare SIGNA Premier MRI Scanners May Have Steel Fittings Risking Injury (2026-02-27), GE Centricity Universal Viewer 6.0/7.0/8.0: Inaccurate Distance Measurements (2022-07-15), and GE Healthcare SIGNA Premier MRI Scanner Recall: Risk of Hearing Loss from Acoustic Noise (2022-06-24). Other recent recalls of similar products include GE Medical Systems Allia IGS 3 Pulse X-Ray System Recall: Electrical Shock Risk (2026-04-20), GE Medical Systems Allia IGS Pulse X-ray System Recall: Risk of Electrical Shock During Service (2026-04-20), and GE Medical Systems Allia IGS 7 Pulse X-Ray System Recall: Electrical Shock Risk for Service Personnel (2026-04-20).

How to tell if you have this one

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.

Brand
GE Healthcare
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Model
Identify if your CardioLab or ComboLab Recording System has model numbers 2088700-002 or 2088700-004 with the listed lot numbers.
Stop Using Immediately
If you have the recalled model with a listed lot number, stop using the device until you contact GE Healthcare for further instructions.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 15 states.

FDA distribution: “Nationwide distribution to CA, CT, FL, IN, MD, MI , MN, MO, NC, NE, NJ, OH, PA, TX, WI. International distribution to Canada, France, India, Japan, Korea (Republic Of), Mexico, Spain, Taiwan.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Connecticut, Florida, Indiana, Maryland, Michigan, Minnesota, Missouri, Nebraska, New Jersey, North Carolina, Ohio, Pennsylvania, Texas, Wisconsin.

Recall timeline

FDA terminated this recall 15 months after the firm started it.

Sep 16, 2019Firm started the recall
Oct 31, 2019FDA classified it Class II
Nov 6, 2019Published in FDA’s Enforcement Report
Dec 16, 2020FDA terminated the recall

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

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/67013-ge-healthcare-cardiolab-combolab-systems-recall-risk-of-electrical-shock">GE Healthcare CardioLab/ComboLab Systems Recall: Risk of Electrical Shock from Patient (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-0257-2020 (September 16, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0257-2020 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.