Class II U.S. Food and Drug Administration

GE Medical Systems, LLC LOGIQ P10 series with software version R4.5.7 recall: The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data

Recall published 1+ years ago

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.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0155-2026
Published
October 22, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
GE Medical Systems, LLC
Product type
Medical devices
Units affected
71 units
Distribution
Nationwide
Made in
United States
Lot / code info
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
UPC codes
00195278464644

Products covered by this recall

LOGIQ P10 series with software version R4.5.7 Model Number 5877534

Check your product

The notice names 1 code you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00195278464644

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

GE Medical Systems, LLC — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: GE Medical Systems, LLC — 3000 N Grandview Blvd, Waukesha, WI, 53188-1615

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was GE Medical Systems, LLC medical devices recalled?

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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00195278464644. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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