CLASS II ONGOING Device recall · Reported 22 Oct 2025 · FDA Enforcement Report
Logiq P10 R4.5 HD ultrasound system with system recalled
GE Medical Systems is recalling Logiq P10 R4.5 HD ultrasound system with system, distributed nationwide in the US. The recall was initiated on 18 Sep 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0156-2026
- FDA event ID
- 97726
- Recalling firm
- GE Medical Systems, Waukesha, WI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Sep 2025
- FDA classified
- 15 Oct 2025
- Reported
- 22 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Imaging Equipment
Timeline
| 18 Sep 2025 | Recall initiated by company | |
| 15 Oct 2025 | Classified by FDA | +27 days |
| 22 Oct 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
Where it was distributed
US Nationwide. Global Distribution.
Questions about this recall
Why was it 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.
Which lots 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 LP9490850
Where was it sold?
US Nationwide. Global Distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 9 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 97726| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Logiq P9 R4.5 ultrasound system with system recalled | GE Medical Systems | Labeling Errors | Nationwide | |
| CLASS II | Logiq P10 series recalled by GE Medical Systems | GE Medical Systems | Labeling Errors | Nationwide |
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|---|---|---|---|---|---|
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Other Imaging Equipment recalls
All 2,347| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |