Root™ with noninvasive blood pressure and temperature 9695Recalls & reported problems
Masimo Corporation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Masimo Root patient monitor, which tracks blood pressure and temperature at the bedside. The 29 reports mostly describe the unit shutting itself off unexpectedly, batteries draining quickly, and temperature readings that fluctuate or seem wrong; no deaths or injuries were reported. There are no recalls naming this device. In the last 12 months there were 8 reports, up from 1 in the prior12 months.
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
- 34
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00843997011907), received between Nov 5, 2017 and Sep 24, 2026 — classified as 34 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (10 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Incorrect Measurement10
- Unexpected Shutdown9
- High Readings5
- Inappropriate or Unexpected Reset3
- Low Readings2
- Defective Alarm1
- Device Displays Incorrect Message1
- Failure to Power Up1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- No Consequences Or Impact To Patient15
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Defective Alarm; Unexpected Shutdown
The customer reported that the device is turning on but shuts down after an hour when the AC is unplugged, with no message or alarm provided. There was no patient impact or consequence reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877317 ↗MalfunctionSep 23, 2026Incorrect Measurement; Low Readings
The device was providing readings that were inaccurately low. There was no patient impact or consequence reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50864334 ↗MalfunctionSep 21, 2026Unexpected Shutdown
The customer reported that the device shuts off after powering despite sufficient battery charge. There was no patient impact or consequence reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50835670 ↗MalfunctionSep 19, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50832417 ↗MalfunctionSep 19, 2026Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50832343 ↗MalfunctionSep 16, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50797011 ↗MalfunctionSep 16, 2026Unexpected Shutdown
The customer reported that "It turns OFF by itself ." There was no patient impact or consequence reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50783997 ↗MalfunctionSep 1, 2026Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50535899 ↗MalfunctionAug 25, 2026Unexpected Shutdown
The customer reported that the device powers off while being used. There was no patient impact or consequence reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50422959 ↗MalfunctionAug 19, 2026Unexpected Shutdown
The customer reported that the Root Powers off on its own. There was no patient impact or consequence reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50313165 ↗MalfunctionAug 12, 2026Inappropriate or Unexpected Reset; Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50217359 ↗MalfunctionNov 10, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED A ROOT "TEMPERATURE ISSUE" AS THE DEVICE WAS "READING [THE] WRONG TEMP." PER ADDITIONAL INFORMATION FROM THE CUSTOMER, "THE READINGS WERE INCONSISTENT AND FLUCTUATED UNEXPECTEDLY." THE FOLLOWING SEQUENCE OF READINGS WERE OBSERVED: 98.2, 99.1, 99.4, AND 98.4. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23519167 ↗MalfunctionNov 10, 2025Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THAT THE DEVICE POWERS OFF AND ON BY ITSELF. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23511448 ↗MalfunctionDec 26, 2024No Apparent Adverse Event; No Apparent Adverse Event
PER MEDWATCH REPORT# (B)(4), THE CUSTOMER REPORTED "WE HAVE SENT SEVERAL MASIMO ROOT 7 PATIENT MONITORS IN FOR REPAIR AND HAVE EXPERIENCED EXTENDED TIME FOR RETURN OF THESE DEVICES. ON AVERAGE WE ARE HAVING TO WAIT 6-8 WEEKS FOR A REPLACEMENT WHICH IS JUST THAT, A NEW UNIT SENT TO US AND NOT THE DEVICE SENT IN FOR REPAIR. THE NEW UNIT ISN'T AN ISSUE FOR US, BUT THE EXCESSIVE TURN-AROUND TIME FOR THIS DEVICE IS. WE HAVE TWO SPARE MONITORS ON HAND TO MAKE SURE WE AREN'T DOWN A ROOM, BUT THOSE UNITS WERE PUT IN PLACE AND AN ADDITIONAL UNIT WAS SENT OUT FOR REPAIR PUTTING US DOWN THREE UNITS WITH LITTLE TO NO RESPONSE FROM MASIMO WHEN AN INQUIRY WAS MADE ABOUT A STATUS UPDATE. THIS LACK OF SUPPLIES AND EQUIPMENT REPLACEMENT IS STARTING TO CAUSE THE POTENTIAL INTERRUPTION TO PATIENT CARE WITHIN OUR FACILITY." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21020678 ↗MalfunctionMar 28, 2023Smoking; Smoking
THE CUSTOMER REPORTED THE "NURSES NOTICED SMOKE COMING FROM THE ROOT." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16627959 ↗MalfunctionJan 7, 2022High Readings; High Readings
THE CUSTOMER REPORTED "BLOOD PRESSURE MONITORING IN WIP BUILDING IS READING TOO HIGH." NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13197676 ↗MalfunctionDec 10, 2021High Readings; High Readings
THE CUSTOMER REPORTED THE DEVICE WAS PROVIDING NIBP READINGS THAT WERE TOO HIGH. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12980904 ↗MalfunctionOct 29, 2021Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE MEASUREMENT IS 5MM OF MERCURY OFF. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12722334 ↗MalfunctionSep 17, 2021Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE BLOOD PRESSURE MEASUREMENT IS CHANGING FROM EXTREME HIGH TO EXTREME LOW. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12492442 ↗MalfunctionOct 16, 2020Incorrect Measurement; Unable to Obtain Readings; Incorrect Measurement; Unable to Obtain Readings
THE CUSTOMER REPORTED THE DEVICE IS NOT GIVING A BLOOD PRESSURE MEASUREMENT AND WHEN IT DOES IT ISN'T ACCURATE. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10692169 ↗MalfunctionNov 15, 2019Overheating of Device; Overheating of Device
THE CUSTOMER REPORTED THE MONITOR RANDOMLY WOULDN'T BE ABLE TO DETECT THE PROBE EVEN WHEN REPLACED WITH A NEW PROBE. ADDITIONALLY WHEN THE MONITOR OVERHEATS, THE TEMPERATURE CHANGES TO CONTINUOUS MODE WITH NO ABILITY TO DO A SPOT CHECK FOR TEMPERATURE. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9328639 ↗MalfunctionOct 25, 2019Low Readings; Low Readings
THE CUSTOMER REPORTED THE ROOT DEVICE IS PROVIDING INACCURATE LOW TEMPERATURE READINGS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9241369 ↗MalfunctionSep 3, 2019Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE DEVICE PROVIDES BLOOD PRESSURE READINGS THAT ARE OFF BY 10 TO 15 POINTS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8955867 ↗MalfunctionJun 6, 2019Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE NIBP DISAPPEARS FROM THE DISPLAY INTERMITTENTLY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8674854 ↗MalfunctionApr 16, 2019Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE DEVICE IS NOT READING CORRECTLY AND THE BLOOD PRESSURE READING IS INCONSISTENT. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8521044 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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