iLab Ultrasound Imaging SystemRecalls & reported problems across all models
Boston Scientific Corporation · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 5 models of iLab Ultrasound Imaging System by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Jan 5, 2018 and Dec 12, 2025 — classified as 22 malfunctions.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (6 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported iLab Ultrasound Imaging System problems
Device problems
- Device Displays Incorrect Message6
- Retraction Problem5
- Application Program Problem4
- Computer Operating System Problem2
- Computer Software Problem2
- No Display/Image2
- Application Network Problem1
- Application Program Freezes or Fails to Launch1
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- No Consequences Or Impact To Patient5
- No Patient Involvement2
- No Known Impact Or Consequence To Patient1
iLab Ultrasound Imaging System models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- iLab Ultrasound Imaging System H749ILAB220CART0COMPUTER, DIAGNOSTIC, PROGRAMMABLE11 reports
- iLab Ultrasound Imaging System H749ILAB100CART0COMPUTER, DIAGNOSTIC, PROGRAMMABLE4 reports
- iLab Ultrasound Imaging System H749ILAB240CART0COMPUTER, DIAGNOSTIC, PROGRAMMABLE3 reports
- iLab Ultrasound Imaging System H749ILAB120CART0COMPUTER, DIAGNOSTIC, PROGRAMMABLE3 reports
- iLab Ultrasound Imaging System H749ILAB120INS0COMPUTER, DIAGNOSTIC, PROGRAMMABLE1 report
Recent iLab Ultrasound Imaging System adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 ↗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 ↗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 ↗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 ↗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 ↗MalfunctionSep 29, 2020Device Displays Incorrect Message; Device Displays Incorrect Message
IT WAS REPORTED THAT CANCELLED PROCEDURE OCCURRED THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A CE ILAB WAS USED. A MOTOR DRIVE UNIT 5 PLUS IS GIVING AN OVERLOAD ERROR. THERE WAS NO PHYSICAL DAMAGE TO THE MDU5 PLUS. THE PROCEDURE WAS NOT COMPLETED DUE TO THE EVENT. NO KNOWN PATIENT CONDITION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10601999 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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