Use caution Medical device recall · FDA · Published August 8, 2023

GE Medical Systems Prucka 3 Amplifiers Recall: Power Supply Failure Risk

GE Medical Systems recalls Prucka 3 Amplifiers (Model P1801PA) and Field Replaceable Units (Model 5875569) used with CardioLab AltiX systems due to potential power supply failure causing inoperability.

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

🇺🇸 FDA recall #Z-2613-2023Medical device GE Medical Systems ›

Use caution until it’s fixed

A diode on the power supply of the Prucka 3 Amplifier used with CardioLab/ComboLab systems could reach elevated temperatures and fail, then power off and become inoperable.

Take action

Contact the company

Recalling firmGE Medical Systems Information Technologies Inc9900 Innovation Dr · Wauwatosa, WI 53226-4856

✎ GovInfoNow plain-language explainer

GE Medical Systems is recalling Prucka 3 Amplifiers (Model P1801PA) and Field Replaceable Units (Model 5875569) used with CardioLab AltiX and ComboLab AltiX systems. The amplifiers could fail due to overheating in the power supply, causing them to power off and become inoperable. Read more at govinfonow.com/recall/57519-ge-medical-systems-prucka-3-amplifiers-recall-power-supply-failure.

Source Summary by GovInfoNow · govinfonow.com/recall/57519-ge-medical-systems-prucka-3-amplifiers-recall-power-supply-failure · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2613-2023

Cite this page

“GE Medical Systems Prucka 3 Amplifiers Recall: Power Supply Failure Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57519-ge-medical-systems-prucka-3-amplifiers-recall-power-supply-failure. Based on FDA recall #Z-2613-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2613-2023%22&limit=1).

The FDA announced on 2023-08-08 that GE Medical Systems Information Technologies Inc is recalling Prucka 3 Amplifiers and Field Replaceable Units due to a power supply diode failure hazard. The agency stated the component could overheat, fail, and render the device inoperable.

How to tell if you have it

Prucka 3 Amplifiers, Model P1801PA
Field Replaceable Units (FRUs), Model 5875569
UPC 00195278507044 (CardioLab)
UPC 00195278507051 (ComboLab)
Serial numbers: SVS22330007SA through SVS23100006SA as listed in record

The hazard

According to the FDA, a diode on the power supply of the Prucka 3 Amplifier used with CardioLab/ComboLab systems could reach elevated temperatures and fail. This failure causes the unit to power off and become inoperable.

Context

GovInfoNow's records show GE Medical Systems Information Technologies Inc has 11 other recalls on record since 2017-07-13. Recent brand recalls include a 2026-07-30 recall of the Carescape Central Station V3 MAS800 for monitoring delays, a 2026-07-20 recall of Portrait Core Services Software V1.0.5 for patient monitoring risks, and a 2026-07-10 recall regarding Patient Monitor Software Vulnerability. Other recent recalls of similar products include the 2025-12-15 Philips Allura Xper FD10F Medical System Recall for electrical short-circuit risk, the 2025-12-15 Philips Allura Xper FD10C Medical System Recall for electrical short-circuit risk, and the 2026-04-20 GE Medical Systems Allia IGS 3 Pulse X-Ray System Recall for electrical shock risk.

How to tell if you have this one

Check for the Prucka 3 Amplifier model P1801PA or Field Replaceable Unit model 5875569 with serial numbers listed in the recall notice. These units were sold with CardioLab AltiX and ComboLab AltiX systems.

Brand
GE Medical Systems
Product
Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Serial Numbers
Verify if your amplifier or field replaceable unit has a serial number from the list provided in the recall notice.
Contact Manufacturer
Reach out to GE Medical Systems for guidance on next steps if your device is affected.

Where it went and when

Where it was distributed

Distributed in 17 states, and outside the U.S.

FDA distribution: “Distribution was made to CA, CO, FL, GA, IL, IN, KY, MA, NC, NJ, OH, OR, PA, SC, TX, VA, and WI. There was government distribution but no military distribution. Foreign distribution was made to Canada, France, Germany, Greece, Ireland,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Colorado, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, New Jersey, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Wisconsin.

Recall timeline

FDA published this recall 50 days after the firm started it.

Aug 8, 2023Firm started the recall
Sep 19, 2023FDA classified it Class II
Sep 27, 2023Published in FDA’s Enforcement Report

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

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using the amplifier immediately?

The recall does not require immediate stop use; however, affected units should be checked and contacted for guidance.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/57519-ge-medical-systems-prucka-3-amplifiers-recall-power-supply-failure">GE Medical Systems Prucka 3 Amplifiers Recall: Power Supply Failure 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-2613-2023 (August 8, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2613-2023 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.