iLab Ultrasound Imaging System H749ILAB220CART0Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729780205), received between Jul 15, 2020 and Dec 12, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Application Program Problem” (2 reports).

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

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2025Application Program Problem; Application Program Problem

  IT WAS REPORTED THAT A DEVICE ISSUE OCCURRED RESULTING IN AN ABORTED PROCEDURE. A CAPITAL EQUIPMENT ILAB ULTRASOUND IMAGING SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, THE ACQUISITION PROCESSOR (ACQ PC) FAILED TO START. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23790970 ↗
• MalfunctionDec 1, 2025Application Program Problem; Application Program Problem

  IT WAS REPORTED THAT A DEVICE ISSUE OCCURRED, RESULTING IN AN ABORTED PROCEDURE. AN ILAB ULTRASOUND IMAGING SYSTEM WAS USED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING PREPARATION PRIOR TO THE IVUS PROCEDURE, IT WAS FOUND THAT THE ACQUISITION PROCESSOR (ACQ PC) COULD NOT START UP. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23684977 ↗
• MalfunctionOct 22, 2025Computer Operating System Problem; Computer Operating System Problem

  IT WAS REPORTED THAT A DEVICE ISSUE OCCURRED, RESULTING IN AN ABORTED PROCEDURE. AN ILAB ULTRASOUND IMAGING SYSTEM WAS USED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE IVUS PROCEDURE, THE DEVICE COULD NOT BE STARTED. THE PROCEDURE WAS NOT COMPLETED AND WAS RESCHEDULED. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT ONLY THE IMAGING PROCEDURE WAS CANCELLED DUE TO THE ILAB ISSUE. THE PATIENT DID NOT RECEIVE THE PLANNED TREATMENT, AND THE PROCEDURE WAS CANCELLED BEFORE THE PATIENT WAS SEDATED. LOCAL ANESTHESIA HAD BEEN PLANNED, BUT WAS NOT ADMINISTERED SINCE THE PROCEDURE WAS CANCELLED BEFOREHAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23358616 ↗
• MalfunctionOct 21, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. A CAPITAL EQUIPMENT ILAB ULTRASOUND IMAGING SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, THE SCREEN WENT BLACK. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23345521 ↗
• MalfunctionOct 15, 2025Operating System Becomes Nonfunctional; Operating System Becomes Nonfunctional

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. A CAPITAL EQUIPMENT ILAB ULTRASOUND IMAGING SYSTEM WAS SELECTED FOR USE. DURING PREPARATION, THE SCREEN TURNED BLUE WHEN THE DEVICE WAS POWERED ON. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23279279 ↗
• MalfunctionOct 15, 2025Image Display Error/Artifact; Device Displays Incorrect Message; Complete Loss of Power; Image Display Error/Artifact; Device Displays Incorrect Message; Complete Loss of Power

  IT WAS REPORTED THAT A DEVICE ISSUE OCCURRED RESULTING IN AN ABORTED PROCEDURE. A CE ILAB WHICH IS USED FOR ULTRASOUND EXAMINATION OF A TARGET LESION. DURING THE PROCEDURE, THE CATHETER DISPLAYED A BLACK SCREEN AFTER INSERTION. UPON REPLACEMENT WITH ANOTHER CATHETER, AN ERROR MESSAGE APPEARED. THE PROCEDURE COULD NOT BE COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23279242 ↗
• MalfunctionJul 31, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE CE ILAB WAS SELECTED FOR EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, IT WAS FOUND THAT THE SCREEN HAD NO DISPLAY. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT ONLY THE IMAGING PROCEDURE WAS CANCELLED BUT THE TREATMENT PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22674116 ↗
• MalfunctionApr 25, 2025Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT A DEVICE ISSUE OCCURRED RESULTING IN AN ABORTED PROCEDURE. A CE ILAB WAS SELECTED FOR THE ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE IVUS PROCEDURE, THE DEVICE AUTOMATICALLY RESTARTED. THE PROCEDURE WAS NOT COMPLETED. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT ONLY THE IMAGING PROCEDURE WAS CANCELLED, AND THAT THE PATIENT HAD A STENT IMPLANTED AS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21907999 ↗
• MalfunctionJan 8, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT A DEVICE ISSUE OCCURRED, RESULTING IN AN ABORTED PROCEDURE. AN ILAB ULTRASOUND IMAGING SYSTEM WAS USED FOR THE INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING PREPARATION, THE PHYSICIAN FOUND THAT THE IVUS CATHETER COULD NOT BE SEARCHED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS ISSUE AND WAS RESCHEDULED. THE PATIENT WAS STABLE, AND NO COMPLICATIONS OR ADDITIONAL INTERVENTIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21099073 ↗
• MalfunctionMar 26, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A CAPITAL EQUIPMENT ISSUE OCCURRED. A CE ILAB, WHICH IS USED FOR ULTRASOUND EXAMINATION OF A TARGET LESION, WAS UNDERGOING ROUTINE INSPECTION. DURING THIS ACTIVITY, IT WAS NOTED THAT A WHEEL HAD FALLEN OFF. THERE WAS NO PROCEDURE OR PATIENT INVOLVED. THE ISSUE WAS RESOLVED ON SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18980833 ↗
• MalfunctionJul 15, 2020Application Network Problem; Application Network Problem

  IT WAS REPORTED THAT NETWORK FAILURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 220V CE ILAB ULTRASOUND IMAGING SYSTEM WAS USED. PRIOR THE PROCEDURE, THE PHYSICIAN FOUND A NETWORK FAILURE IN THE EQUIPMENT SYSTEM. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THE PATIENT IS STABLE, NO PATIENT COMPLICATION OR OTHER ADDITIONAL INTERVENTION REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10277156 ↗