Natus 61-000300Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00382830056335), received between Dec 6, 2021 and May 5, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Fell” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2023Device Fell; Device Fell

  RETCAM ENVISION, SYSTEM WITH FA - CUSTOMER REPORTED THE MONITOR IS SAGGING AND STATED THAT THERE WAS POTENTIAL FOR INJURY, AS THE MONITOR FIRST FELL DURING IMAGE ACQUISITION. ANOTHER MEMBER OF STAFF IN THE OR WAS ABLE TO STABILIZE IT AT THAT TIME. CUSTOMER CONFIRMED THAT THE ISSUE WAS RESOLVED HOWEVER, IT TOOK ABOUT 2.5 FULL REVOLUTIONS OF THE ADJUSTMENT SCREW TO HOLD THE MONITOR UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16875036 ↗
• MalfunctionDec 6, 2021No Display/Image; Misfocusing; No Display/Image; Misfocusing

  PART: 61-000300 RETCAM ENVISION, SYSTEM WITH FA - WE HAVE A COMPLAINT FROM THE DOCTOR ABOUT THE INSTABILITY OF THE LENS IN THE CAMERA AND THE MOVEMENT. THE DOCTOR IS UNSATISFIED WITH THE IMAGE QUALITY AND SOMETIMES GAVE HIM WRONG DIAGNOSE. NO INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12932292 ↗