FDAClass IIOctober 22, 2025

LOGIQ P10 R4.5 HD ultrasound system with system recall

LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535

Why was LOGIQ P10 R4.5 HD ultrasound system with system 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
Recalling firm
GE Medical Systems, LLC
Quantity
31 units
Distribution
US Nationwide. Global Distribution.
Recall date
October 22, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls