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Lower risk Medical device recall · FDA · Published September 18, 2025

GE Medical LOGIQ P10 R4.5 HD Ultrasound System Recall: Inaccurate Liver Steatosis

GE Medical recalls LOGIQ P10 R4.5 HD ultrasound systems with software version R4.5.7. Model 5877535 may show inaccurate liver fat measurements, risking wrong medical decisions.

🇺🇸 FDA recall #Z-0156-2026Medical deviceGE Medical ›
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Recalling firmGE Medical Systems, LLC3000 N Grandview Blvd · Waukesha, WI 53188-1615
✎ GovInfoNow plain-language explainer

GE Medical is recalling certain LOGIQ P10 R4.5 HD ultrasound systems with software version R4.5.7. These systems might display incorrect liver fat measurements, which could lead to inappropriate medical treatments. Read more at govinfonow.com/recall/51251-ge-medical-logiq-p10-r4-5-hd-ultrasound-system-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/51251-ge-medical-logiq-p10-r4-5-hd-ultrasound-system-recall · Updated October 6, 2026 · FDA enforcement record: FDA #Z-0156-2026

Cite this page

“GE Medical LOGIQ P10 R4.5 HD Ultrasound System Recall: Inaccurate Liver Steatosis.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/51251-ge-medical-logiq-p10-r4-5-hd-ultrasound-system-recall. Based on FDA recall #Z-0156-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0156-2026%22&limit=1).

GE Medical Systems, LLC voluntarily recalled the LOGIQ P10 R4.5 HD ultrasound system with software version R4.5.7 on Sept. 18, 2025, according to the FDA. The device may display inaccurate liver steatosis values, potentially leading to inappropriate clinical decisions.

How to tell if you have it

  • GE Medical LOGIQ P10 R4.5 HD ultrasound system
  • Model Number 5877535
  • System software version R4.5.7
  • UDI-DI: 00195278464668
  • Serial Numbers: LPZ490338, LPZ490347, LPZ490339, LPZ490147, LPZ490292, LPZ490019, LPZ490252, LPZ490348, LPZ490303, LPZ490304, LPZ490305, LPZ490306, LPZ490340, LPZ490350, LPZ490341, LPZ440658, LPZ440673, LPZ440674, LPZ490337, LPZ440641, LPZ440192, LPZ440258, LPZ440694, LPZ440695, LPZ440692, LPZ440632, LPZ440185, LPZ440107, LPZ440168, LPZ440046, LPZ440549, LP9490850

The hazard

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

Context

GovInfoNow's records show GE Medical Systems, LLC has 27 other recalls on record since March 30, 2018. Recent similar product recalls include the Philips EPIQ Elite Ultrasound System Recall for Inaccurate Blood Flow Measurements (Aug. 7, 2026), the PIE Medical Imaging 3mensio Workstation Software Recall for Measurement Errors in Vascular Imaging (May 7, 2026), and the LH One Step Ovulation Test Device Recall for False Results Risk Medical Errors (Nov. 22, 2025).

How to tell if you have this one

Check for model number 5877535 and software version R4.5.7 on the device. The system serial numbers listed in the recall include LPZ490338 through LPZ440549.

  • Brand
    GE Medical
  • Category
    Medical device
FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    US Nationwide. Global Distribution.
Recall numberProduct, codes & lotsQuantity
Z-0155-2026LOGIQ P10 series with software version R4.5.7 Model Number 5877534; 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 LPX44150171 units
Z-0156-2026LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535; Model Number 5877535 UDI-DI: 00195278464668, Serial Numbers: LPZ490338 LPZ490347 LPZ490339 LPZ490147 LPZ490292 LPZ490019 LPZ490252 LPZ490348 LPZ490303 LPZ490304 LPZ490305 LPZ490306 LPZ490340 LPZ490350 LPZ490341 LPZ440658 LPZ440673 LPZ440674 LPZ490337 LPZ440641 LPZ440192 LPZ440258 LPZ440694 LPZ440695 LPZ440692 LPZ440632 LPZ440185 LPZ440107 LPZ440168 LPZ440046 LPZ440549 LP949085032 units
Z-0157-2026LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533; 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 LP944098637 units
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Verify the software version on your LOGIQ P10 R4.5 HD ultrasound system. If it shows R4.5.7, it is part of the recall.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide. Global Distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 34 days after the firm started it.

1. Firm started the recall: Sep 18, 202512. FDA classified it Class II: Oct 15, 202523. Published in FDA’s Enforcement Report: Oct 22, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. 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-0156-2026 (September 18, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0156-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on October 6, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA