ModerateClass IIOngoing

FDA Devices recall · Reported July 10, 2024

Prucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology recording system and ComboLab AltiX hemodynamic and electrophysiology recording system; and Field Replacement Units spare part #5875569 (Assy CLABIII AMP 128CH 100-240V 50-60HZ).

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on July 10, 2024. Severity: Moderate. Recall number: Z-2258-2024.

Q: Where was the recalled product distributed?

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, Japan, Republic of Korea, and Singapore..

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-2258-2024) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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 in…

Recall #: Z-2258-2024
Affected scope: 145 units
Initiated: April 22, 2024

Compiled from official public sources by the editorial process. · Updated August 2026

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Ge Medical Systems Information Technologies Inc recalled Prucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology recording s… - a moderate-severity action.

Prucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology recording s… was recalled by Ge Medical Systems Information Technologies Inc in July 10, 2024. Reason: Capacitors in certain Prucka 3 Amplifiers used with CardioLab / ComboLab systems could fail resulting in tran…. Check the official notice for the remedy. Verify recall #Z-2258-2024 with the FDA Devices before acting.

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The recall

Ge Medical Systems Information Technologies Inc issued this moderate-severity FDA Devices recall-Capacitors in certain Prucka 3 Amplifiers used with CardioLab / ComboLab systems could fail resulting in tran….

Moderate
severity level: 145 units
affected scope: Class II
classification: July 10, 2024
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2258-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-2258-2024) was formally reported on July 10, 2024, with the manufacturer initiating the action on April 22, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Ge Medical Systems Information Technologies Inc is listed as the recalling firm, operating out of Milwaukee, WI. Federal records list the affected scope as 145 units.

The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: 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,…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Moderate

Affected scope

145 units

Related Recalls

3 from same agency

Product description

Prucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology recording system and ComboLab AltiX hemodynamic and electrophysiology recording system; and Field Replacement Units spare part #5875569 (Assy CLABIII AMP 128CH 100-240V 50-60HZ).

Reason for 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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Ongoing
Recall number	Z-2258-2024
Date reported	July 10, 2024
Date initiated	April 22, 2024
Recalling firm	Ge Medical Systems Information Technologies Inc
Firm location	Milwaukee, WI
Affected scope	145 units
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, Japa…

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

145 units units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-2258-2024) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on July 10, 2024. Severity: Moderate. Recall number: Z-2258-2024.

Where was the recalled product distributed? ▼

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, Japan, Republic of Korea, and Singapore..

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-2258-2024) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 10, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.