INVOS DL5100C-USRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521185883), received between May 30, 2023 and Jun 17, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Low Readings” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2025Device Alarm System; Incorrect Measurement; Communication or Transmission Problem; Device Alarm System; Incorrect Measurement; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING USE, AFTER CONNECTING THE MONITORING PROBE, IT WAS FOUND THAT THE DATA COULD NOT BE READ NORMALLY. IT WAS IMMEDIATELY REPLACED TO CONTINUE MONITORING THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22237847 ↗
• MalfunctionJan 13, 2025Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE LITERATURE SOURCE, A PROSPECTIVE OBSERVATIONAL STUDY WAS CONDUCTED TO ASSESS CEREBRAL AND SPLANCHNIC OXYGENATION IN PREMATURE INFANTS WITH PROSTAGLANDIN DEPENDENT CONGENITAL HEART DISEASE USING NEAR-INFRARED SPECTROSCOPY. NIRS (NEAR-INFRARED SPECTROSCOPY) MEASUREMENTS WERE OBTAINED USING THE DEVICE. PROBES WERE PLACED ON THE FOREHEAD AND ON THE ABDOMEN TO MEASURE SPLANCHNIC AND CEREBRAL RSO2 VALUES. A TOTAL OF 24 PATIENTS WERE INITIALLY ENROLLED IN THE STUDY BETWEEN (B)(6) 2016 AND (B)(6) 2021. HOWEVER, ONE CONTROL PARTICIPANT WAS EXCLUDED DUE TO NIRS DEVICE MALFUNCTION, RESULTING IN ABERRANT READINGS. THE FINAL DATA SET INCLUDED 897 MEASUREMENTS FROM 23 PARTICIPANTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21143406 ↗
• MalfunctionJul 26, 2023Low Readings; Low Readings

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD ERROR LOW CHANNEL ONE WHILE ATTACHED TO PATIENT THAT HAPPENED SEVERAL TIMES IN TERMITTENTLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17401287 ↗
• MalfunctionJul 25, 2023Low Readings; Low Readings

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD ERROR LOW CHANNEL ONE WHILE ATTACHED TO PATIENT THAT HAPPENED SEVERAL TIMES IN TERMITTENTLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17390212 ↗
• MalfunctionMay 30, 2023Display or Visual Feedback Problem; Low Readings; Data Problem; Display or Visual Feedback Problem; Low Readings; Data Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE'S WAVEFORMS WERE NOT DISPLAYING ON THE SCREEN. READING SHOWED 20S BUT THE DISPLAY ONLY WENT DOWN TO 30. THE USER COULD NOT SEE THE DATA. IT WAS AGREED THAT THERE WAS NO ISSUE WITH THE NUMBERS BUT THE DISPLAY NEEDED TO BE CHANGED.  THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17022948 ↗