Quick Facts at a Glance
- Recall Date
- September 18, 2025
- Hazard Level
- HIGH
- Brand
- GE Medical Systems
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- GE Medical Systems
- Product type
- Ultrasound System
- Model numbers
- 5877535
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 18, 2025
Reported by FDA DEVICE
October 22, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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 You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact GE Medical Systems, LLC or your healthcare provider for instructions. Notification method: Letter
About This Product
The LOGIQ P10 is a higher-end ultrasound system used by clinicians for diagnostic imaging. Version R4.5.7 refers to the installed software on the affected unit.
Why This Is Dangerous
UGAP data may misrepresent liver steatosis. This can lead to incorrect assessment of liver fat and potentially inappropriate patient management.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics using the affected LOGIQ P10 systems may need to re-scan patients or adjust interpretations based on unreliable UGAP data. The recall involves 31 units with nationwide and global distribution.
Practical Guidance
How to identify if yours is affected
- Check model number 5877535 on the device label or startup screen.
- Review serial numbers against the recall list.
- Confirm UGAP data is not used for decision-making until guidance is issued by GE Medical Systems.
Where to find product info
FDA recall page and GE HealthCare recall communications.
What timeline to expect
Refunds or replacements follow GE Medical Systems recall process, typically within weeks to a couple of months depending on availability.
If the manufacturer is unresponsive
- Document all contact attempts with GE Medical Systems.
- Escalate to hospital risk management and consider filing a recall complaint with FDA if the manufacturer is unresponsive.
- Keep copies of all recall notices and correspondence.
How to prevent similar issues
- Regularly check for recall updates from GE HealthCare and FDA.
- Verify device software compatibility before updates.
- Maintain an inventory of devices with model numbers and serials to quickly identify affected units.
Documentation advice
Keep the recall notice, serial numbers, model numbers, and all correspondence with GE Medical Systems for records.
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Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Serial numbers listed in recall
- Distribution: US Nationwide and Global
- Hazard: UGAP data may misrepresent liver steatosis
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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