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

Logiq P10 series recalled by GE Medical Systems

GE Medical Systems is recalling Logiq P10 series, 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 5877534 UDI-DI: 00195278464644, Serial Numbers: LPX441358 LPX441335 LPX440894 LPX440598 LPX440898 LPX441357 LPX441328 LPX441402 LPX441407 LPX441405 LPX441326 LPX441126 LPX441406 LPX441403 LPX441404 LPX441439 LPX441440 LPX441327 LPX441043 LPX441399 LPX441370 LPX441422 LPX441369 LPX441001 LPX441447 LPX440990 LPX441374 LPX441376 LPX441428 LPX441453 LPX441427 LPX440999 LPX441373 LPX441420 LPX441384 LPX441375 LPX441421 LPX441424 LPX441371 LPX441425 LPX441426 LPX441367 LPX441368 LPX441377 LPX441382 LPX441455 LPX441423 LPX441430 LPX441018 LPX441417 LPX441437 LPX441445 LPX441265 LPX441446 LPX441412 LPX441451 LPX441462 LPX441448 LPX441450 LPX441475 LPX441457 LPX441444 LPX490014 LPX441099 LPX441452 LPX441441 LPX441442 LPX441408 LPX441343 LPX441517 LPX441501

Quantity recalled71 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-0155-2026
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: Medical Software

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 P10 series with software version R4.5.7 Model Number 5877534

Where it was distributed

US Nationwide. Global Distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Model 5877534 UDI-DI: 00195278464644, Serial Numbers: LPX441358 LPX441335 LPX440894 LPX440598 LPX440898 LPX441357 LPX441328 LPX441402 LPX441407 LPX441405 LPX441326 LPX441126 LPX441406 LPX441403 LPX441404 LPX441439 LPX441440 LPX441327 LPX441043 LPX441399 LPX441370 LPX441422 LPX441369 LPX441001 LPX441447 LPX440990 LPX441374 LPX441376 LPX441428 LPX441453 LPX441427 LPX440999 LPX441373 LPX441420 LPX441384 LPX441375 LPX441421 LPX441424 LPX441371 LPX441425 LPX441426 LPX441367 LPX441368 LPX441377 LPX441382 LPX441455 LPX441423 LPX441430 LPX441018 LPX441417 LPX441437 LPX441445 LPX441265 LPX441446 LPX441412 LPX441451 LPX441462 LPX441448 LPX441450 LPX441475 LPX441457 LPX441444 LPX490014 LPX441099 LPX441452 LPX441441 LPX441442 LPX441408 LPX441343 LPX441517 LPX441501

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 9 Oct 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 P9 R4.5 ultrasound system with system recalled	GE Medical Systems	Labeling Errors	Nationwide

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