SYNK 0240031010Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327056075), received between Apr 21, 2020 and May 13, 2021 — classified as 8 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (8 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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2021No Display/Image; Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11816842 ↗
• MalfunctionApr 21, 2020Communication or Transmission Problem; No Display/Image; Communication or Transmission Problem

  IT WAS REPORTED THAT THERE WAS IMAGE LOSS OF MORE THAN A MINUTE DURING PROCEDURE. PLEASE NOTE THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTS OF ADVERSE CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9984209 ↗
• MalfunctionApr 21, 2020Communication or Transmission Problem; No Display/Image; Communication or Transmission Problem

  IT WAS REPORTED THAT THERE WAS IMAGE LOSS OF MORE THAN A MINUTE DURING PROCEDURE. PLEASE NOTE THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTS OF ADVERSE CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9984208 ↗
• MalfunctionApr 21, 2020Communication or Transmission Problem; No Display/Image; Communication or Transmission Problem

  IT WAS REPORTED THAT THERE WAS IMAGE LOSS OF MORE THAN A MINUTE DURING PROCEDURE. PLEASE NOTE THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTS OF ADVERSE CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9983468 ↗
• MalfunctionApr 21, 2020Communication or Transmission Problem; No Display/Image; Communication or Transmission Problem

  IT WAS REPORTED THAT THERE WAS IMAGE LOSS OF MORE THAN A MINUTE DURING PROCEDURE. PLEASE NOTE THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTS OF ADVERSE CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9983464 ↗
• MalfunctionApr 21, 2020Communication or Transmission Problem; No Display/Image; Communication or Transmission Problem

  IT WAS REPORTED THAT THERE WAS IMAGE LOSS OF MORE THAN A MINUTE DURING PROCEDURE. PLEASE NOTE THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTS OF ADVERSE CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9983463 ↗
• MalfunctionApr 21, 2020Communication or Transmission Problem; No Display/Image; Communication or Transmission Problem

  IT WAS REPORTED THAT THERE WAS IMAGE LOSS OF MORE THAN A MINUTE DURING PROCEDURE. PLEASE NOTE THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTS OF ADVERSE CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9983456 ↗
• MalfunctionApr 21, 2020Wireless Communication Problem; No Display/Image; Wireless Communication Problem

  IT WAS REPORTED THAT THERE WAS IMAGE LOSS OF MORE THAN A MINUTE DURING PROCEDURE. PLEASE NOTE THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTS OF ADVERSE CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9983374 ↗