iLab Ultrasound Imaging System H749ILAB240CART0Recalls & reported problems
Boston Scientific Corporation · Cart 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729777694), received between Jan 31, 2024 and Mar 18, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Application Program Problem” (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.
Reports received per month
Most reported problems
Device problems
- Application Program Problem1
- Computer Operating System Problem1
- Computer Software Problem1
- Failure to Power Up1
- Poor Quality Image1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 18, 2025Computer Operating System Problem; Computer Operating System Problem
IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. A CAPITAL EQUIPMENT ILAB ULTRASOUND IMAGING SYSTEM WAS SELECTED FOR USE. DURING PROCEDURE, IMAGING FAILED TO START ERROR OCCURRED. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21630910 ↗MalfunctionJun 25, 2024Computer Software Problem; Failure to Power Up; Computer Software Problem; Failure to Power Up
IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. A CAPITAL EQUIPMENT ILAB ULTRASOUND IMAGING SYSTEM WAS SELECTED FOR USE. DURING PROCEDURE, ERROR 1002 OCCURRED AND ACQUISITION PC DID NOT RESTART AFTER RESET. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19608606 ↗MalfunctionJan 31, 2024Poor Quality Image; Application Program Problem; Poor Quality Image; Application Program Problem
IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. A CAPITAL EQUIPMENT ILAB ULTRASOUND IMAGING SYSTEM WAS SELECTED FOR USE. DURING PROCEDURE, A FIRST RUN WAS SUCCESSFULLY PERFORMED. WHEN A SECOND WAS ATTEMPTED, NO IMAGE WAS DISPLAYED. THE MDU5+ COMPONENT SEEMED TO WORK BUT THE IMAGE WAS BLACK. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18614851 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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