LOGIQ recallZ-0156-2026 · GE Medical Systems, LLC · initiated Sep 18, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from GE Medical Systems, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Software design
What the company is doing
An URGENT MEDICAL DEVICE CORRECTION notification letter dated 9/18/25 was sent to customers. Actions to be taken by Customer/User For LOGIQ P9 and LOGIQ P10 series ultrasound systems with system software version R4.5.7, discontinue using the UGAP feature (please see Appendix for product identification). You may continue using other imaging features. After the correction has been implemented, please destroy the installation media for software R4.5.7 at your site. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please retain this document for your records. Please complete and return the attached acknowledgement form to [email protected]. GE HealthCare will correct all affected products at no cost to you. A GE HealthCare representative will contact you to arrange for the correction. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Recall details
- Recall number
- Z-0156-2026
- Status
- Open, Classified
- Initiated by the company
- Sep 18, 2025
- Posted by the FDA
- Oct 15, 2025
- Recalling firm
- GE Medical Systems, LLC
- Quantity
- 31 units
- Product code
- IYN
- FDA submissions
- K214039
- Distribution
- US Nationwide. Global Distribution.
Product description
LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- LOGIQ P10 R4.5 HDGE Ultrasound Korea Ltd. · System, imaging, pulsed doppler, ultrasonic1 recall0 reports
Product lines
Other devices under the same FDA submission
3 devices cleared under K214039 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- NA IC9-RSGE Healthcare Austria GmbH & Co OG · System, imaging, pulsed echo, ultrasonic55 reports
- LOGIQ P9 R4.5GE Ultrasound Korea Ltd. · System, imaging, pulsed echo, ultrasonic1 recall0 reports
- LOGIQ P10 R4.5GE Ultrasound Korea Ltd. · System, imaging, pulsed echo, ultrasonic1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 97726).
- Z-0155-2026 · Open, ClassifiedLOGIQ P10 series with software version R4.5.7 Model Number 5877534
- Z-0157-2026 · Open, ClassifiedLOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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