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

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556630082), received between Apr 13, 2018 and Feb 13, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2026Application Program Problem

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE IMAGE MANAGEMENT SYSTEM HAD CORRUPTED SOFTWARE. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MINUTES, USING A STORZ COMPETITOR DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24332094 ↗
• MalfunctionApr 19, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE IMAGE MANAGEMENT SYSTEM SCREEN WAS FROZEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19144175 ↗
• MalfunctionNov 30, 2023Smoking; Smoking

  IT WAS REPORTED THAT DURING SET UP, THE IMAGE MANAGEMENT SYSTEM UNIT STARTED TO SMOKE WHEN TURNED ON. THERE WAS A SMITH AND NEPHEW BACK UP DEVICE AVAILABLE AND NO SURGICAL DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18238742 ↗
• MalfunctionNov 24, 2021Overheating of Device; Output below Specifications; Noise, Audible; Overheating of Device; Output below Specifications; Noise, Audible

  IT WAS REPORTED THAT THE IMAGE MANAGEMENT SYSTEM FAN WAS VERY LOUD, ALSO DID NOT HAVE ANALOG OUTPUT, WAS OVERHEATING AND FREEZING. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12872889 ↗
• MalfunctionJan 29, 2019Reset Problem

  IT WAS REPORTED THAT THE DEVICE HAD TO BE RESET DURING MID CASE. NO PATIENT INJURY OR SIGNIFICANT DELAY WERE REPORTED. UNKNOWN IF THERE WAS A BACK UP DEVICE AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8287251 ↗
• MalfunctionApr 13, 2018No Display/Image

  IT WAS REPORTED THAT THE DEVICE HAD THE SCREEN BLACK. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7428851 ↗