iLab Ultrasound Imaging System H749ILAB100CART0Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729761235), received between Sep 4, 2018 and Sep 18, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2018Retraction Problem; Device Displays Incorrect Message; Retraction Problem; Device Displays Incorrect Message

  IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. AN ILAB ULTRASOUND IMAGING SYSTEM WAS USED IN CONJUNCTION WITH AN OPTICROSS IMAGING CATHETER AND PULLBACK SLED TO VIEW THE TARGET LESION. DURING PROCEDURE, AN IMAGE FROZE DURING IMAGING AND MDU OVERLOAD MESSAGE WAS DISPLAYED. THE DEVICE FROZE DURING PULLBACK. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7886036 ↗
• MalfunctionSep 17, 2018Retraction Problem; Connection Problem; Retraction Problem; Connection Problem

  IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. A 100V ILAB ULTRASOUND IMAGING SYSTEM WAS USED IN CONJUNCTION WITH AN IMAGING CATHETER AND A PULLBACK SLED TO VIEW THE TARGET LESION. HOWEVER, PULLBACK WAS UNABLE TO BE PERFORMED. LOST INTERNAL COMPUTER CONNECTION OCCURRED. THE ILAB MAIN SWITCH WAS TURNED OFF/ON AND IT RESTORED TEMPORARILY, BUT THE ISSUE OCCURRED AGAIN. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7881363 ↗
• MalfunctionSep 14, 2018Retraction Problem; Device Displays Incorrect Message; Detachment of Device or Device Component; Application Program Freezes or Fails to Launch; Retraction Problem; Device Displays Incorrect Message; Detachment of Device or Device Component; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. AN ILAB ULTRASOUND IMAGING SYSTEM WAS USED IN CONJUNCTION WITH AN OPTICROSS IMAGING CATHETER AND PULLBACK SLED TO VIEW THE TARGET LESION. DURING USAGE, THE EQUIPMENT FROZE AND IT WAS UNABLE TO PERFORM PULLBACK. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7878907 ↗
• MalfunctionSep 4, 2018Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. A 100V ILAB ULTRASOUND IMAGING SYSTEM WAS USED IN CONJUNCTION WITH AN IMAGING CATHETER AND A PULLBACK SLED. DURING THE PROCEDURE, AUTO PULLBACK WAS UNABLE TO BE PERFORMED AND AUTOMATIC PULLBACK FAILED. HOWEVER, THE TECHNICIAN REPORTED THAT AFTER SLED RESEATING THE ISSUE WAS SOLVED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7842879 ↗