Rad-97 9797Recalls & reported problems
Masimo Corporation · Rad-97 with non-invasive blood pressure · Class 2
Quick summary
This Masimo Rad-97 patient monitor tracks vital signs like oxygen levels and blood pressure. Its 84 adverse event reports describe blood pressure readings that stay inaccurate even after calibration, sensors that lose readings or give slow results, unexpected shutdowns, resets, and alarms that don't sound. No deaths or injuries were reported, and most reports noted no patient impact. No recalls name this device. Reports in the latest 12 months (6) were fewer than the prior 12 months (12).
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 85
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 85 adverse event reports that list this exact device (DI 00843997012775), received between Mar 23, 2018 and Sep 29, 2026 — classified as 85 malfunctions.
The most frequently reported specific device problem is “Unexpected Shutdown” (19 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.
Reports received per month
Most reported problems
Device problems
- Unexpected Shutdown19
- Sensing Intermittently18
- Incorrect Measurement17
- Inappropriate or Unexpected Reset12
- High Readings6
- No Audible Alarm3
- Low Readings2
- Overheating of Device2
Patient problems
- No Clinical Signs, Symptoms or Conditions64
- No Consequences Or Impact To Patient20
- Bruise/Contusion1
- Erythema1
- Pain1
Recent adverse event reports
The 25 most recent of 85 reports, in the reporter's own words as published by the FDA.
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 50927224 ↗MalfunctionSep 28, 2026Unexpected Shutdown
The customer reported that the device will not power on most of the time. if it does turn on, it shuts off by itself. There was no patient impact or consequence reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910730 ↗MalfunctionSep 24, 2026Sensing Intermittently
The customer reported that the device connects for 2 mins and stops reading. TB20 connection is loose. There was no patient impact or consequence reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877491 ↗MalfunctionSep 19, 2026Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50832405 ↗MalfunctionSep 9, 2026Unexpected Shutdown
The customer reported that when powering on, turns off by itself, and only powers on with the power cord. Per customer, "No error messages are displayed." There was no patient impact or consequence reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50684702 ↗MalfunctionDec 8, 2025Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED A "SATURATION PROBLEM (WHICH SEEMS RELATED TO THE CIRCUIT BOARD)" WITH THE RAD-97. PER ADDITIONAL INFORMATION FROM THE CUSTOMER, THE DEVICE "LOST READING WITHOUT TOUCHING ANYTHING." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23741527 ↗MalfunctionNov 25, 2025Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THAT THE DEVICE IS "TURNING OFF DURING WORK". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23653334 ↗MalfunctionOct 31, 2025Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem
THE CUSTOMER REPORTED THAT THE SENSOR PROVIDED SLOW AND INACCURATE READING[S] OF SPO2 AND PR. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23444051 ↗MalfunctionOct 16, 2025Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THE RAD-97 WAS "NOT STAYING ON." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23319541 ↗MalfunctionSep 4, 2025Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THAT THE DEVICE SATURATION IS INTERMITTENT. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22974301 ↗MalfunctionAug 25, 2025Use of Device Problem; Use of Device Problem
THE CUSTOMER REPORTED A "PAINFUL EXPERIENCE" WITH THE RAD-97 AS SHE "RECEIVED A BRUISE ON THE LEFT ARM AND RED MARKS ON BOTH ARMS WHICH DISSIPATED HOURS AFTER." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: Bruise/Contusion; Erythema; Pain
MAUDE report 22891469 ↗MalfunctionAug 14, 2025Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THAT THE DEVICE HAS AN "INTERMITTENT LOSS OF SPO2 AND HEART RATE SIGNAL". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22811593 ↗MalfunctionAug 12, 2025Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THE RAD-97 "SUDDENLY SHUTDOWN AFTER 3 MINUTES." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22786613 ↗MalfunctionAug 5, 2025Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THAT AFTER A FEW MINUTES OF MONITORING, THE DEVICE STOPS MONITORING. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22723248 ↗MalfunctionAug 1, 2025Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THAT THE DEVICE "TURNS OFF BY ITSELF, FOR NO REASON". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22689290 ↗MalfunctionJul 14, 2025Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THE RAD-97 "SHUTS OFF." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22501147 ↗MalfunctionApr 24, 2025Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THE RAD-97 "POWER[ED] OFF BY ITSELF." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21905543 ↗MalfunctionFeb 20, 2025Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THAT ONCE THE DEVICE IS "TURNED ON FOR A FEW MINUTES, IT STOPS TAKING MEASUREMENTS". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21428416 ↗MalfunctionJan 16, 2025Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED "FOUND BATTERY IS FULLCHARGED 100% AFTER 5 MINUTES SUDDENLY SHUTDOWN". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21174916 ↗MalfunctionSep 24, 2024Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THAT THE DEVICE "TURNS OFF AUTOMATICALLY DURING OPERATION AND THERE IS NO VISIBLE SIGNS OF DEMAGE." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20293230 ↗MalfunctionDec 15, 2023Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED AN "INTERMITTENT CONNECTION OF SATS LEAD". THERE WAS NO CONSEQUENCE OR IMPACT TO THE PATIENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18336385 ↗MalfunctionDec 5, 2023Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE SPO2 KEEPS LOSING SIGNAL FOR THE RAD-97 DEVICE. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18271250 ↗MalfunctionSep 7, 2023Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THE RADICAL-97 TURNS OFF ON ITS OWN. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17705662 ↗MalfunctionSep 7, 2023Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THE RAD-97 TURNS OFF AFTER A FEW MINUTES. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17705621 ↗MalfunctionJun 21, 2023Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE SPO2 MEASUREMENT IS INTERRUPTED SPORADICALLY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17176204 ↗
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- McKesson Cardiology Hemo 14.0Change Healthcare Canada Company · Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)2 recalls2 deaths2 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.