LOGIQ P10 R4.5 HDRecalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K214039); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Sep 18, 2025Class IIOpen, Classified

   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.

   Z-0156-2026 · Root cause: Software design · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K214039. One submission often covers many models, so check the product and lot details in each record.

• Z-0157-2026 · Sep 18, 2025 · Open, Classified
  LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533
• Z-0155-2026 · Sep 18, 2025 · Open, Classified
  LOGIQ P10 series with software version R4.5.7 Model Number 5877534