Rad-57™ Pulse CO-Oximeter™ 9216Recalls & reported problems
Masimo Corporation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Masimo Rad-57 pulse oximeter, a handheld device that reads oxygen saturation and other vital signs. The 71 reports mostly describe the screen going blank or showing wrong numbers, plus readings that are too low or too high, and units that shut off on their own or drain batteries quickly. No deaths and no injuries were reported, and most reports note no effect on the patient. No recalls name this device. In the last 12 months there were 8 reports, up from 1 in the prior 12 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
- 70
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 00843997006163), received between Jun 2, 2017 and May 12, 2026 — classified as 70 malfunctions.
The most frequently reported specific device problem is “Display or Visual Feedback Problem” (34 reports).
1 other recall cover devices cleared under the same FDA submission (K080238); 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. 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
- Display or Visual Feedback Problem34
- Incorrect Measurement21
- Low Readings5
- High Readings3
- Unexpected Shutdown3
- Device Alarm System2
- No Display/Image2
- Sensing Intermittently2
Patient problems
- No Consequences Or Impact To Patient41
- No Clinical Signs, Symptoms or Conditions28
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 70 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 12, 2026Unexpected Shutdown
THE CUSTOMER REPORTED "IT TURNS OFF EVERY NOW AND THEN." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25145982 ↗MalfunctionApr 30, 2026No Display/Image; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED THE RAD-57 "DOESN'T DISPLAY CORRECT NUMBERS." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED. IT IS UNKNOWN WHICH PARAMETER WAS BEING MEASURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25038934 ↗MalfunctionApr 25, 2026Incorrect Measurement
THE CUSTOMER REPORTED THAT THE RAD-57 IS NOT GIVING ACCURATE RESULTS. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24993088 ↗MalfunctionApr 6, 2026Device Alarm System; Incorrect Measurement
THE CUSTOMER REPORTED INACCURATE CO2 READINGS. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER, "THE PARAMETER IS SPCO, DURING USE, NO PATIENT IMPACT, NO ALARMS OR MESSAGED." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24787499 ↗MalfunctionMar 23, 2026Premature Discharge of Battery; Incorrect Measurement; Sensing Intermittently
THE CUSTOMER REPORTED THAT THE DEVICE "BATTERIES STARTED DRAINING QUICKLY; PARAMETERS SEEMED OFF BEFORE PULLING OUT OF FIELD. WOULD INTERMITTENTLY CUT OFF; PARAMETERS WOULD SPORADICALLY JUMP BACK AND FORTH. DOES NOT PERFORM AS IT SHOULD. NO DAMAGE NOTED TO UNIT". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24664021 ↗MalfunctionJan 14, 2026Incorrect Measurement
THE CUSTOMER REPORTED THAT THE DEVICE PROVIDED ALTERED CO VALUES, CO VALUES ARE "INCORRECT". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24064886 ↗MalfunctionJan 7, 2026Sensing Intermittently
THE CUSTOMER REPORTED "INTERMITTENT MONITORING" WITH THE RAD-57. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23987098 ↗MalfunctionFeb 11, 2025Device Alarm System; Device Alarm System
THE CUSTOMER REPORTED THE RAD-57 "WAS ON A PATIENT AND STOPPED WORKING WITHOUT WARNING, [AND] NO LONGER WILL POWER ON NOW." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21360593 ↗MalfunctionJul 17, 2024High Readings; High Readings
THE CUSTOMER REPORTED THE DEVICE SHOWS VALUES THAT ARE TOO HIGH. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19764758 ↗MalfunctionApr 26, 2024Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THE RAD-57 WAS "POWERING OFF INTERMITTENTLY." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19194097 ↗MalfunctionApr 26, 2024Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED THE RAD-57 WAS "POWERING OFF INTERMITTENTLY." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19194057 ↗MalfunctionJul 26, 2023High Readings; High Readings
THE CUSTOMER REPORTED THE SPMET VALUES WERE READING HIGHER THAN THEY SHOULD. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17401953 ↗MalfunctionOct 29, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem
PER MEDWATCH REPORT: "WHEN WE RECEIVED THE MONITOR IT WAS MISSING THE REUSABLE SENSOR WHICH IS NECESSARY TO HAVE." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15696617 ↗MalfunctionOct 4, 2022Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE DEVICE PROVIDES INACCURATE SPO2 VALUES. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15539585 ↗MalfunctionSep 24, 2022Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED INACCURATE SPCO MEASUREMENTS. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15478807 ↗MalfunctionMay 9, 2022Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE DEVICE PROVIDES IMPOSSIBLE READING FOR CO. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14342702 ↗MalfunctionMar 9, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THE SEGMENTS OF THE SCREEN AREN'T LIGHTING UP. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13715924 ↗MalfunctionMar 8, 2022Low Readings; Low Readings
THE CUSTOMER REPORTED THE DEVICE MEASURED INACCURATE OXYGEN SATURATION. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13691095 ↗MalfunctionDec 30, 2021Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED INACCURATE READING SPO2. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13122310 ↗MalfunctionDec 16, 2021Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE DEVICE WAS INACCURATE. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13023315 ↗MalfunctionNov 7, 2021Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE DEVICE "GIVES A FALSE MEASUREMENT OF SPCO AFTER 3 MINS IT GIVES A CORRECT VALUE." NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12763492 ↗MalfunctionOct 21, 2021Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE DEVICE SHOWS BETWEEN 12 AND 25 FOR SPCO. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12677563 ↗MalfunctionSep 16, 2021Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED "INCORRECT READINGS ON DEVICE." NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12485375 ↗MalfunctionJun 10, 2021Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE DEVICE SHOWS CONTINUOUS READING OF 8 OR HIGHER FOR EVERYBODY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11980001 ↗MalfunctionMay 20, 2021Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THAT THE RAD-57 PROVIDED INACCURATE READINGS. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11855037 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K080238. One submission often covers many models, so check the product and lot details in each record.
- Z-0338-2016 · Oct 28, 2015 · Terminatedrainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; RAINBOW DCI-dc8, SpO2/SpCO/SpMet, Part No. 2407; RAINBOW DCI, SpO2/SpCO/SpMet, Part No. 2696; RAINBOW
Other Oximeter devices
- Trilogy Trilogy100 Ventilator, InternationalRespironics, Inc. · Oximeter8 deaths2,493 reports
- Trilogy Trilogy 202 Ventilator, United StatesRespironics, Inc. · Oximeter2 deaths1,594 reports
- HAMILTON-G5 159001Hamilton Medical AG · Oximeter18 deaths1,440 reports
- Trilogy Trilogy100 Ventilator, GermanyRespironics, Inc. · Oximeter696 reports
- Model EMV+ Vent, Army, MRI 799-EMVP-04Zoll Medical Corporation · Oximeter1 death605 reports
- Trilogy Evo, O2, Japan JP2100X16BRespironics, Inc. · Oximeter4 recalls5 deaths342 reports
- Model EMV+ Vent, Army, COMMERCIAL 799-EMVP-01-01Zoll Medical Corporation · Oximeter1 death497 reports
- HAMILTON-G5 159002Hamilton Medical AG · Oximeter3 deaths451 reports
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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