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iLab Ultrasound Imaging System H749ILAB120INS0Recalls & reported problems

Boston Scientific Corporation · Installed Basic System · Class 2

All models of iLab Ultrasound Imaging System (5)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729810186), received between Feb 16, 2021 and Feb 16, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (1 report).

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.

Most reported problems

Device problems

  • Device Displays Incorrect Message1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 16, 2021Device Displays Incorrect Message; Device Displays Incorrect Message

    IT WAS REPORTED THAT CANCELLED PROCEDURE OCCURRED. WHILE AN ILAB ULTRASOUND IMAGING SYSTEM WAS IN USE DURING A PROCEDURE, THE UNIT ENCOUNTERED AN ERROR WHICH COULD NOT BE CLEARED UNTIL AFTER THE SYSTEM WAS REBOOTED. BECAUSE THE ERROR INVOLVED MEMORY STORAGE, IT WAS DECIDED ALL STORED CASES SHOULD BE ARCHIVED AND DELETED. THE PROCEDURE WAS CANCELLED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11335054 ↗

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Sources and updates

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