Rad-67 9794Recalls & reported problems
Masimo Corporation · Pulse CO-Oximeter · Class 2
Quick summary
This Masimo Rad-67 pulse oximeter measures blood hemoglobin and oxygen levels. The 25 reports mostly describe readings that were too high compared with lab results, with no deaths and no injuries mentioned. No recalls name this device.
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
- 25
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00843997012812), received between Sep 27, 2019 and Nov 14, 2022 — classified as 25 malfunctions.
The most frequently reported specific device problem is “High Readings” (13 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
Device problems
- High Readings13
- Incorrect Measurement10
- Low Readings2
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- No Consequences Or Impact To Patient11
- Anemia1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 14, 2022High Readings; High Readings
THE CUSTOMER REPORTED THE DEVICE PROVIDED VALUES THAT WERE TOO HIGH. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15794953 ↗MalfunctionAug 11, 2022High Readings; High Readings
THE CUSTOMER REPORTED INACCURATE HIGH SPHB VALUES COMPARED TO A COMPETITOR DEVICE AND LAB RESULTS. WHEN THE LAB TEST (CONDUCTED 2 DAYS POST USE OF THE MASIMO DEVICE) INDICATED THE PATIENT'S SPHB WAS TOO LOW, THE HOSPITAL DECIDED TO ADMIT THE PATIENT. THE PATIENT RECEIVED A BLOOD TRANSFUSION.
Patient problems: Anemia
MAUDE report 15214264 ↗MalfunctionJul 18, 2022High Readings; High Readings
THE CUSTOMER REPORTED INACCURATE HIGH SPHB VALUES COMPARED TO LAB RESULTS. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15048407 ↗MalfunctionJul 18, 2022High Readings; High Readings
THE CUSTOMER REPORTED INACCURATE HIGH SPHB VALUES COMPARED TO LAB RESULTS. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15048318 ↗MalfunctionJul 18, 2022High Readings; High Readings
THE CUSTOMER REPORTED INACCURATE HIGH SPHB VALUES COMPARED TO LAB RESULTS. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15048290 ↗MalfunctionJul 18, 2022High Readings; High Readings
THE CUSTOMER REPORTED INACCURATE HIGH SPHB VALUES COMPARED TO LAB RESULTS. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15048286 ↗MalfunctionMay 17, 2022Low Readings; Low Readings
THE CUSTOMER REPORTED LOW SPHB READINGS. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14417491 ↗MalfunctionMay 17, 2022High Readings; High Readings
THE CUSTOMER REPORTED HIGH SPHB READINGS. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14417240 ↗MalfunctionMar 10, 2022High Readings; High Readings
THE CUSTOMER REPORTED THE DEVICE PROVIDED HIGH READINGS COMPARED TO BLOOD LABS. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13726562 ↗MalfunctionJan 21, 2022High Readings; High Readings
THE CUSTOMER REPORTED THE DEVICE PROVIDED A HIGH SPHB VALUE WHEN COMPARED TO A BLOOD DRAW. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13321534 ↗MalfunctionDec 30, 2021High Readings; High Readings
THE CUSTOMER REPORTED INACCURATE SPCO, MEASUREMENTS WERE TOO HIGH REGARDING CLINICAL SITUATION. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13122299 ↗MalfunctionOct 15, 2021Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED INACCURATE MEASUREMENTS. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12642776 ↗MalfunctionOct 7, 2021Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED DISSATISFACTION WITH THE RESULTS OF THE MEASUREMENT OF HEMOGLOBIN, TOO BIG MEASUREMENT DEVIATIONS COMPARED TO THE BIOLOGY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12595075 ↗MalfunctionJul 22, 2021High Readings; High Readings
THE CUSTOMER REPORTED THE DEVICE PROVIDED A HIGH SPHB VALUE WHEN COMPARED TO A BLOOD DRAW. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12213173 ↗MalfunctionJul 29, 2020Low Readings; Low Readings
THE CUSTOMER REPORTED THE DEVICE WAS READING LOWER HEMOGLOBIN LEVELS ON PATIENTS THAN THE RESULTS OF BLOOD GAS ANALYZERS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10341662 ↗MalfunctionOct 14, 2019High Readings; High Readings
THE CUSTOMER REPORTED THAT THE DEVICE PROVIDED HIGH READINGS.NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9188689 ↗MalfunctionSep 29, 2019Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THAT THE DEVICE PROVIDED HIGH SPHB READINGS WHEN COMPARED TO A BLOOD DRAW. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9132509 ↗MalfunctionSep 29, 2019High Readings; High Readings
THE CUSTOMER REPORTED THE DEVICE PROVIDED INACCURATE HIGH SPHB VALUES WHEN COMPARED TO THE LAB RESULTS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9132508 ↗MalfunctionSep 27, 2019Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THAT THE DEVICE PROVIDED HIGH SPHB READINGS WHEN COMPARED TO A BLOOD DRAW. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9132128 ↗MalfunctionSep 27, 2019Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE DEVICE IS PROVIDING HIGH SPHB READINGS WHEN COMPARED TO A BLOOD DRAW. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9132127 ↗MalfunctionSep 27, 2019Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE DEVICE IS PROVIDING HIGH SPHB READINGS WHEN COMPARED TO A BLOOD DRAW. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9132121 ↗MalfunctionSep 27, 2019Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE DEVICE PROVIDED INACCURATE HIGH SPHB VALUES WHEN COMPARED TO THE LAB RESULTS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9132120 ↗MalfunctionSep 27, 2019Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE DEVICE IS PROVIDING HIGH SPHB READINGS WHEN COMPARED TO A BLOOD DRAW. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9132119 ↗MalfunctionSep 27, 2019Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE DEVICE PROVIDED INACCURATE HIGH SPHB VALUES WHEN COMPARED TO THE LAB RESULTS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9132116 ↗MalfunctionSep 27, 2019Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THAT THE DEVICE PROVIDED HIGH SPHB READINGS WHEN COMPARED TO A BLOOD DRAW. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9132115 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.