660 72200242Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010566676), received between May 29, 2018 and May 12, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Computer Operating System 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 16, 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.

• MalfunctionMay 12, 2021Overheating of Device; Protective Measures Problem; Overheating of Device; Protective Measures Problem

  IT WAS REPORTED THAT THE 660 HD IMS HAD A MESSAGE OF OVER TEMPERATURE. NO CASE REPORTED; THEREFORE, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11815897 ↗
• MalfunctionAug 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, WHEN TURNING THE IMAGE MANAGEMENT SYSTEM ON, THE WINDOWS APP DID NOT LOAD. THE OPERATION WAS PERFORMED WITHOUT THE DEVICE, SINCE THERE WAS NOT A BACK-UP DEVICE AVAILABLE. THE SURGERY WAS DELAYED FOR LESS THAN 30 MIN. THE PATIENT WAS NOT INJURED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8915195 ↗
• MalfunctionOct 26, 2018Computer Operating System Problem

  IT WAS REPORTED THAT THE DEVICE HAS FAULTY HARD DRIVE. NOT REBOOTING AT ALL. SYSTEM IS HANGING FOR OVER AN HOUR. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8010029 ↗
• MalfunctionMay 29, 2018Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE DEVICE CAUSES THE LIGHT TO DIM. NO BACK-UP DEVICE WAS AVAILABLE. NOR DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7551102 ↗