Radical-7® 9500Recalls & reported problems

Summary

The FDA's MAUDE database contains 174 adverse event reports that list this exact device (DI 00843997008358), received between Oct 13, 2017 and Sep 30, 2026 — classified as 1 death, 173 malfunctions.

The most frequently reported specific device problem is “Unexpected Shutdown” (64 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 174 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  The customer reported there was a sudden drop in SpO2 readings. There was no patient impact or consequence reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941805 ↗
• MalfunctionSep 29, 2026Device Alarm System; Unexpected Shutdown

  The customer reported that "after power on the device turn off by itself with no alarm or error message". There was no patient impact or consequence reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927223 ↗
• MalfunctionSep 25, 2026Device Alarm System; Unexpected Shutdown

  The customer reported that the device powers off when the sensor is connected with no error message or alarm. There was no patient impact or consequence reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50894932 ↗
• DeathSep 9, 2026Incorrect Measurement; Unable to Obtain Readings

  The customer reported, per the original information received on (b)(6) 2026: "We will be arranging the delivery of the below-mentioned devices for investigation, as they have been involved in an incident of suspected patient harm." On August 10, 2026 Masimo received additional information that a "baby was born on the (b)(6) 2026 at 18:10 via spontaneous vaginal delivery. Born in good condition, subsequently collapse at 20 minutes of live and passed away at 20:10. Masimo Radical7 Bedside Pulse CO-Oximeter never picked up the baby oxygen saturation and the heart rate before and after the collapse. The heart rate picked up by the machine was not consistent with what was auscultated with the stethoscope (Heart rate picked up by machine well below 100 bpm, auscultated with stethoscope 135 bpm)." Natural birth, mum arrived at 4pm and delivered at 6pm. Mum has quite severe anxiety, reports from nurses were that mum felt quite uncontrolled.

  Patient problems: Insufficient Information

  MAUDE report 50699810 ↗
• MalfunctionJun 14, 2026Device Alarm System; Unexpected Shutdown

  THE CUSTOMER REPORTED THE RADICAL-7 SWITCHES OFF AFTER ABOUT ONE MINUTE EVEN THOUGH THE BATTERY IS SHOWING A 100% CHARGE. WHEN THE DEVICE IS PLACED INTO THE CHARGING CRADLE, THE BATTERY INDICATOR READS 0%. PER ADDITIONAL INFORMATION FROM THE CUSTOMER, NO ALERTS WERE PROVIDED WHEN THE POWER ISSUE OCCURRED. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25496880 ↗
• MalfunctionJun 12, 2026High Readings

  THE CUSTOMER REPORTED THE RADICAL-7 AND RADIUS VSM WERE "READING HIGHER THAN SECONDARY PULSE OXIMETER USED AND SEEMS TO BE OVER READING. PATIENTS WHO HAVE KNOWN DESATURATIONS (DUE TO PULMONARY FIBROSIS), REMAIN WITHIN NORMAL LIMITS ON MASIMO, HOWEVER DESATURATION NOTED ON OTHER DEVICES." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25482092 ↗
• MalfunctionJun 8, 2026Device Alarm System; Unexpected Shutdown

  THE CUSTOMER REPORTED THAT THE DEVICE INDICATES A FULL CHARGE WHEN USED ON ITS OWN, BUT WHEN IT IS CONNECTED TO THE DOCKING STATION AND THE POWER CORD IS UNPLUGGED, THE UNIT SHUTS DOWN WITH NO MESSAGE OR ALARM. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25437666 ↗
• MalfunctionMay 31, 2026Defective Alarm; Unexpected Shutdown

  THE CUSTOMER REPORTED THAT THE DEVICE WILL CHARGE AND THEN AS SOON AS IT'S REMOVED [FROM THE DOCKING STATION] IT DIES STRAIGHT AWAY EVEN AFTER BATTERY CHANGED AND SOFTWARE UPDATE. THE LED DOESN'T FLASH OR ALARM, THE DEVICE WILL JUST TURN OFF AND WON'T TURN ON UNTIL PLUGGED INTO A BASE. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25344402 ↗
• MalfunctionMay 28, 2026Unexpected Shutdown

  THE CUSTOMER REPORTED THAT THE RADICAL-7 TURNS OF BY ITSELF AFTER 2 MINUTES. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25313021 ↗
• MalfunctionApr 14, 2026Inappropriate or Unexpected Reset

  THE CUSTOMER REPORTED THAT THE DEVICE IS POWERING ON BUT STARTING AGAIN. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24868288 ↗
• MalfunctionApr 14, 2026Inappropriate or Unexpected Reset

  THE CUSTOMER REPORTED THAT THE DEVICE IS POWERING ON BUT STARTING AGAIN. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24868283 ↗
• MalfunctionApr 14, 2026Inappropriate or Unexpected Reset

  THE CUSTOMER REPORTED THAT THE DEVICE IS POWERING ON BUT STARTING AGAIN. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24868279 ↗
• MalfunctionApr 14, 2026Unexpected Shutdown

  THE CUSTOMER REPORTED THAT THE POWER REPEATEDLY TURNS ON AND OFF. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24868239 ↗
• MalfunctionApr 14, 2026Unexpected Shutdown

  THE CUSTOMER REPORTED THAT THE DEVICE POWERED OFF WITHOUT LOW BATTERY ON ITS OWN. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24868092 ↗
• MalfunctionApr 7, 2026Inappropriate or Unexpected Reset

  THE CUSTOMER REPORTED THAT THE DEVICE KEEPS POWER CYCLING, IT DOES NOT STAY ON. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24811902 ↗
• MalfunctionApr 7, 2026Unexpected Shutdown

  THE CUSTOMER REPORTED THAT "THE DEVICE, DESPITE BEING FULLY CHARGED, SUDDENLY SWITCHES OFF." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24811719 ↗
• MalfunctionApr 6, 2026Unexpected Shutdown

  THE CUSTOMER REPORTED THAT DESPITE BEING FULLY CHARGED, THE DEVICE SWITCHES OFF. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24787893 ↗
• MalfunctionApr 6, 2026Unexpected Shutdown

  THE CUSTOMER REPORTED THAT THE UNIT WILL POWER OFF ON ITS OWN. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24787518 ↗
• MalfunctionApr 1, 2026Inappropriate or Unexpected Reset; Unexpected Shutdown

  THE CUSTOMER REPORTED THAT UNIT KEEPS RESETTING. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24754690 ↗
• MalfunctionMar 5, 2026Device Alarm System; Unexpected Shutdown

  THE CUSTOMER REPORTED THE RADICAL-7 "BATTERY SEEMS TO BE FAULTY" AS "THE DEVICE SHUT DOWN SUDDENLY WITH NO LOW-BATTERY ALERT. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24516846 ↗
• MalfunctionMar 4, 2026Unexpected Shutdown

  THE CUSTOMER REPORTED THAT THE DEVICE HAS A CHARGING PROBLEM. WHEN LEAVING THE UNIT RUNNING ON BATTERY ONCE THE CHARGE GETS TO 75% THE UNIT SHUTS OFF. THERE WAS NO ALARM OR ERROR NOTIFICATION. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24504454 ↗
• MalfunctionMar 2, 2026Unexpected Shutdown

  THE CUSTOMER REPORTED THE RADICAL-7 "SHUTS OFF SUDDENLY WHILE IN USE." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24477717 ↗
• MalfunctionFeb 13, 2026Application Program Freezes or Fails to Launch

  THE CUSTOMER REPORTED THE RADICAL-7 "FREEZES AND STOPS FUNCTIONING INTERMITTENTLY." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24338246 ↗
• MalfunctionFeb 13, 2026Unexpected Shutdown

  THE CUSTOMER REPORTED THE RADICAL-7 "POWERS OFF BY ITSELF." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24338027 ↗
• MalfunctionFeb 3, 2026Data Problem

  THE CUSTOMER REPORTED THE RADICAL-7S' "MODE CHANGED UNINTENTIONALLY." PER ADDITIONAL INFORMATION FROM THE CUSTOMER, "THE MODE AUTOMATICALLY SWITCHES FROM PEDIATRIC MODE TO NEONATAL MODE." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24254905 ↗