GreenLight HPS 0010-0070Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00878953000206), received between Oct 13, 2021 and Oct 13, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 13, 2021Failure to Power Up; Device Displays Incorrect Message; Failure to Power Up; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE UNIT WAS DISPLAYING ERROR 832 CODE (TEST FAILED) OCCURRED. THE UNIT DOES NOT POWER ON. THERE WAS NO PATIENT COMPLICATION DUE TO THIS EVENT; HOWEVER, THE PROCEDURE WAS NOT COMPLETED. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE REAR PANEL BOARD AND DIODE POWER SUPPLY. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12625669 ↗