660HD-E IMAGE MANAGEMENT SYSTEM 72204668Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00885556623695), received between Sep 7, 2017 and Apr 30, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2025Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, DURING THE IMAGE MANAGEMENT SYSTEM 660 HD-E STARTUP PROCESS, A SOFTWARE ISSUE OCCURRED, DISPLAYING AN "AUTOMATIC REPAIR" BLUE SCREEN. THE PROCEDURE WAS COMPLETED AFTER A SIGNIFICANT SURGICAL DELAY GREATER THAN 30MIN USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21932248 ↗
• MalfunctionMar 1, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, WHEN THE RIGHT CAMERA BUTTON WAS PRESSED TO RECORD, IT WAS GOING TO WHITE BALANCE SETTINGS INSTEAD. IT WAS BROUGHT IN A DIFFERENT CAMERA HEAD TO TEST IF THAT WAS WHERE THE DEFAULT WAS AND IT WAS NOT. THE IMAGE MANAGEMENT SYSTEM BEGAN TAKING VIDEOS WITHOUT ASSISTANCE ONE AFTER THE OTHER. IT WOULD NOT COME OFF OF RECORDING NOR WOULD IT ALLOW TO CANCEL OR CLOSE OUT OF ANYTHING. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18818396 ↗
• MalfunctionJun 5, 2020Image Display Error/Artifact; Image Display Error/Artifact

  IT WAS REPORTED THAT THE DISPLAY SIGNAL WAS NOT STABLE DURING OPERATION. THERE WAS A DELAY GREATER THAN 30 MINUTES AND THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NO INJURY OR COMPLICATIONS TO THE USER OR PATIENT WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10123982 ↗
• MalfunctionAug 23, 2019No Display/Image; Unexpected Shutdown; No Display/Image; Unexpected Shutdown

  IT WAS REPORTED THAT THE 660HD-E IMAGE MANAGEMENT SYSTEM HAD FOUND UNSATISFACTORY AS THE UNIT HAD AN ¿INTERMITTENT AUTO SHUTTING DOWN DURING SURGERY". 30 MINUTES DELAY AND A BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8927890 ↗
• MalfunctionAug 20, 2019No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING THE SURGERY THE DEVICE HAD A BLANK TOUCH SCREEN PANEL WITH FAILED APPLICATION " UNABLE TO OPERATE". NO PATIENT INJURIES OR DELAY REPORTED. BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8913174 ↗
• MalfunctionJul 16, 2019No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE 660HD-E IMAGE MANAGEMENT SYSTEM HAD FOUND UNSATISFACTORY DUE TO LOSS OF HDSDI VIDEO SIGNAL. A FINE VERTICAL LINE COVERING THE WHOLE ENTIRE DISPLAY SCREEN AFTER 5-15 MIN OF STILL AND VIDEO CAPTURING, DISABLING THE APPLICATION SCREEN OF 660HD-E IMS. POSSIBLE DEFECTIVE VIDEO CAPTURE CARD. 30 MINUTES DELAY AND A BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8795834 ↗
• MalfunctionMar 8, 2019No Device Output

  IT WAS REPORTED THAT DURING ARTHROSCOPY PROCEDURE, THE DEVICE DID NOT GET A VIDEO SIGNAL. THERE WAS A SIGNIFICANT DELAY GREATER THAN 30 MINUTES. A BACK UP DEVICE WAS AVAILABLE AND NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8405334 ↗
• MalfunctionMay 4, 2018Operating System Becomes Nonfunctional

  IT WAS REPORTED THAT THE 660 HD UNIT FROZE UP. THE UNIT WAS RESTARTED AND NOTHING CHANGED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7489093 ↗
• MalfunctionSep 7, 2017Overheating of Device

  IT WAS REPORTED THE 660HD IMAGE MANAGEMENT SYSTEM OVERHEATED. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6849586 ↗