CLASS II ONGOING Device recall · Reported 22 Oct 2025 · FDA Enforcement Report

Logiq P9 R4.5 ultrasound system with system recalled

GE Medical Systems is recalling Logiq P9 R4.5 ultrasound system with system, distributed nationwide in the US. The recall was initiated on 18 Sep 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel 5877533 UDI-DI: 00195278464637, Serial Numbers: LP9490416 LP9490175 LP9490393 LP9490399 LP9490376 LP9490463 LP9443017 LP9442472 LP9443231 LP9442094 LP9443291 LP9443230 LP9440403 LP9442483 LP9440972 LP9440166 LP9440237 LP9440933 LP9440348 LP9442196 LP9440631 LP9440926 LP9441099 LP9441225 LP9441097 LP9440929 LP9441030 LP9440921 LP9441035 LP9440507 LP9440920 LP9440459 LP9440460 LP9441332 LP9442656 LP9443022 LP9440986

Quantity recalled37 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0157-2026
FDA event ID: 97726
Recalling firm: GE Medical Systems, Waukesha, WI
Classification: Class II
Status: Ongoing
Recall initiated: 18 Sep 2025
FDA classified: 15 Oct 2025
Reported: 22 Oct 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Imaging Equipment

Timeline

18 Sep 2025	Recall initiated by company
15 Oct 2025	Classified by FDA	+27 days
22 Oct 2025	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.

Product as listed by the FDA

LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533

Where it was distributed

US Nationwide. Global Distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Model 5877533 UDI-DI: 00195278464637, Serial Numbers: LP9490416 LP9490175 LP9490393 LP9490399 LP9490376 LP9490463 LP9443017 LP9442472 LP9443231 LP9442094 LP9443291 LP9443230 LP9440403 LP9442483 LP9440972 LP9440166 LP9440237 LP9440933 LP9440348 LP9442196 LP9440631 LP9440926 LP9441099 LP9441225 LP9441097 LP9440929 LP9441030 LP9440921 LP9441035 LP9440507 LP9440920 LP9440459 LP9440460 LP9441332 LP9442656 LP9443022 LP9440986

Where was it sold?

US Nationwide. Global Distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 97726

This product is part of a recall event; the main page for the event is Logiq P10 R4.5 HD ultrasound system with system recalled.

Reported	Class	Recall	Company	Reason	Where
22 Oct 2025	CLASS II	Logiq P10 R4.5 HD ultrasound system with system recalled	GE Medical Systems	Labeling Errors	Nationwide
22 Oct 2025	CLASS II	Logiq P10 series recalled by GE Medical Systems	GE Medical Systems	Labeling Errors	Nationwide

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