GE Medical Prucka 3 Amplifier Recall: Display Oscillations Risk
GE Medical recalls Prucka 3 Amplifier Model P1801PA used with CardioLab/ComboLab systems due to capacitor failure causing display oscillations and ECG waveform issues. Affected units have specific serial numbers.
Lower-risk recall
Capacitors in certain Prucka 3 Amplifiers used with CardioLab / ComboLab systems could fail resulting in transient oscillations on the display and inability to view surface and intracardiac ECG waveforms.
Contact the company
What happened, in plain English
GE Medical is recalling Prucka 3 Amplifiers with model #P1801PA that are used with CardioLab or ComboLab systems. These amplifiers can have capacitors fail, causing temporary display oscillations and making it impossible to view ECG waveforms during medical procedures. Read more at govinfonow.com/recall/55339-ge-medical-prucka-3-amplifier-recall-display-oscillations-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/55339-ge-medical-prucka-3-amplifier-recall-display-oscillations-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2258-2024
Cite this page
“GE Medical Prucka 3 Amplifier Recall: Display Oscillations Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/55339-ge-medical-prucka-3-amplifier-recall-display-oscillations-risk. Based on FDA recall #Z-2258-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2258-2024%22&limit=1).
Why it’s dangerous
Capacitors in certain Prucka 3 Amplifiers used with CardioLab or ComboLab systems can fail, causing temporary display oscillations and preventing healthcare workers from viewing surface and intracardiac ECG waveforms during medical procedures.
Who’s affected
Healthcare professionals using the Prucka 3 Amplifier with CardioLab or ComboLab systems are most at risk. Affected units have specific serial numbers listed in the recall notice.
How to tell if you have this one
Check if your Prucka 3 Amplifier has model #P1801PA and serial numbers listed in the recall notice. The amplifier is used with CardioLab AltiX or ComboLab AltiX systems. The serial numbers start with 'SVS23' followed by specific digits.
- Brand
GE Medical Systems- Product
Prucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology recording system and ComboLab AltiX- Category
Medical device
What to do — step by step
Check Amplifier Serial Number
Look for the serial number on your Prucka 3 Amplifier, which starts with 'SVS23' followed by specific digits.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 21 states.
FDA distribution: “Worldwide - US Nationwide distribution in the states of AK, AZ, CA, CO, FL, GA, IL, KY, MA, ME, MN, MO, NC, NJ, NY, OH, OR, PA, TN, TX, and WA. The countries of Belgium, Canada, Czech Republic, France, Germany, Ireland, Israel, Italy,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alaska, Arizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Maine, Massachusetts, Minnesota, Missouri, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Washington.
Recall timeline
FDA published this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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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-2258-2024 (April 22, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2258-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.