iLab Ultrasound Imaging System H749ILAB120CART0Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729810032), received between Jan 5, 2018 and Sep 29, 2020 — 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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionJul 15, 2020Application Program Problem; Application Program Problem

  IT WAS REPORTED THAT FAILURE TO RECORD OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 120V CE ILAB ULTRASOUND IMAGING SYSTEM WAS USED. DURING PROCEDURE, THE UNIT WAS NOT RECORDING. TWO CATHETERS WERE ATTEMPTED, BUT THE UNIT STILL DID NOT RECORD, SO THE PHYSICIAN ABORTED THE PROCEDURE. NO OTHER DETAILS WERE GIVEN AND NO SPECIFIC ERROR MESSAGE WAS PROVIDED. THERE WERE NO KNOWN CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10277423 ↗
• MalfunctionJan 5, 2018Retraction Problem; Retraction Problem

  SAME CASE AS: 2134265-2018-00109 AND 2134265-2018-00110 . IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. A 120V ILAB ULTRASOUND IMAGING SYSTEM WAS USED IN CONJUNCTION WITH AN OPTICROSS¿ IMAGING CATHETER AND A PULLBACK SLED TO VIEW THE TARGET LESION. DURING THE PROCEDURE, IT WAS NOTICED THAT MOTORDRIVE UNIT DOES NOT PULLBACK. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7167141 ↗