RAD-G 9895Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00843997013789), received between Mar 18, 2024 and Sep 24, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Unexpected Shutdown” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K213676); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Feb 15, 2024Open, Classified

   Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.

   Z-1539-2024 · Root cause: Material/Component Contamination · FDA record ↗

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.

• MalfunctionSep 24, 2026Application Program Freezes or Fails to Launch

  The customer reported, "The only information we have received is that the touchscreen freezes and doesn't work intermittently, It will be like this for a few minutes and then works again. There was also an issue with the rear casing coming away."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50879903 ↗
• MalfunctionFeb 18, 2026Unexpected Shutdown

  THE CUSTOMER REPORTED THAT THE DEVICE POWERED OFF AND WILL NOT TURN BACK ON. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24384869 ↗
• MalfunctionDec 27, 2025Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER REPORTED THE RAD-G WAS "BEING A LITTLE TEMPERAMENTAL" AS THE DEVICE "SWITCHES OFF RANDOMLY." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23901427 ↗
• MalfunctionAug 19, 2025Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER REPORTED THE RAD-GS "WOULD INTERMITTENTLY TURN THEMSELVES OFF WITHOUT ANYONE TOUCHING IT." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22846659 ↗
• MalfunctionApr 26, 2024Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER REPORTED THE RAD-G "AUTOMATICALLY TURN[S] ON AND OFF." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19197547 ↗
• MalfunctionMar 18, 2024Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER REPORTED THE RAD-G DEVICE "TURNING OFF ON INTERMITTENTLY". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18924214 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K213676. One submission often covers many models, so check the product and lot details in each record.

• Z-1536-2024 · Feb 15, 2024 · Open, Classified
  Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,