LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
Summary
The FDA issued a Class II for LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model by GE Medical Systems, LLC. Reason: The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially.
Details
Source
Device Recall
External ID
Z-0156-2026
Action Date
2025-10-22
Status
Ongoing
Category
device
Product Description
LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
Lot/Code Info: 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
Quantity Affected: 31 units
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.
Distribution
US Nationwide. Global Distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-18
Company
Waukesha, WI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 237 device recalls issued in the same week, part of 403 device-related FDA actions this month.
GE Medical Systems, LLC has 138 FDA actions in our database, including 121 recalls and 17 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (GE Medical Systems, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GE Medical Systems, LLC have FDA actions?
GE Medical Systems, LLC has 138 FDA actions in our database, including 121 recalls and 17 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0156-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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