RD SETRecalls & reported problems across all models

We found 12 models of RD SET by Masimo Corporation in the FDA's device registry (GUDID). Together they are named in 49 adverse event reports in the FDA's MAUDE database, received between Feb 21, 2018 and Sep 28, 2026 — classified as 49 malfunctions.

The most frequently reported specific device problem is “Sensing Intermittently” (16 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

RD SET recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Apr 21, 2023Class IIOpen, Classified

   TC-I tip clip sensor may produce readings outside the accuracy specification.

   Z-1983-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported RD SET problems

RD SET models

12 models, most reported first. Each model has its own page with its reports, recalls and device details.

• RD SET 4053

  Oximeter
  1 recall3 reports
• RD SET 4478

  Oximeter
  13 reports
• RD SET 4054

  Oximeter
  10 reports
• RD SET 4013

  Oximeter
  5 reports
• RD SET 4473

  Oximeter
  4 reports
• RD SET 4474

  Oximeter
  4 reports
• RD SET 4052

  Oximeter
  3 reports
• RD SET 4479

  Oximeter
  3 reports
• RD SET 4003

  Oximeter
  1 report
• RD SET 4055

  Oximeter
  1 report
• RD SET 4472

  Oximeter
  1 report
• RD SET 4477

  Oximeter
  1 report

Recent RD SET adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Low Readings

  The customer reported that a baby undergoing phototherapy, with the SpO2 sensor shielded from light by a strip. The sensor had been reading accurately for the past two days. The baby has had stable vital signs since birth. Suddenly, the SpO2 drops to 30%. After removing the baby from phototherapy and waking him up, he showed no clinical signs of desaturation. After replacing the oxygen saturation sensor, the SpO2 level returned to 96%. There was no patient impact or consequence reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910647 ↗
• MalfunctionApr 6, 2026Failure to Sense

  THE CUSTOMER REPORTED ¿PLUGGED THE NICU OXIMETER PROBE INTO THE CABLE AND IT SAID, "FAULTY PROBE" AND WOULD NOT WORK RIGHT AFTER OPENING". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24787390 ↗
• MalfunctionMar 30, 2026Unable to Obtain Readings; Sensing Intermittently; Failure to Sense

  THE CUSTOMER REPORTED THAT THE SENSOR STOP(S) FUNCTIONING (EMITTER LIGHT SWITCH OFF), NO ALARM ON "MINDRAY MONITOR". DISCONNECT AND RECONNECT THE SENSOR DIDN'T CHANGE THE SITUATION. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24710248 ↗
• MalfunctionMar 4, 2026Low Readings

  THE CUSTOMER REPORTED THAT "THE SPO2 VALUE MEASURED BY MINDRAY/MASIMO WAS "FALSELY" LOW COMPARED WITH FORMER PHILIPS/FAST MONITOR WITH NELLCOR SENSOR AND ABG SAO2: MINDRAY/MASIMO - LEFT HAND: SPO2 = 86; PHILIPS MP2/FAST - FOOT: SPO2 = 94; ABG: SAO2 = 92.4; 4 - 6 PTS DIFFERENCE". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24512615 ↗
• MalfunctionMar 4, 2026Low Readings

  THE CUSTOMER REPORTED THAT "THE SPO2 VALUE MEASURED BY MINDRAY/MASIMO WAS "FALSELY" LOW COMPARED WITH FORMER PHILIPS/FAST MONITOR WITH NELLCOR SENSOR AND ABG SAO2: MINDRAY/MASIMO - LEFT HAND: SPO2 = 86; PHILIPS MP2/FAST - FOOT: SPO2 = 94; ABG: SAO2 = 92.4; 4 - 6 PTS DIFFERENCE". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24506685 ↗
• MalfunctionFeb 19, 2026Low Readings

  THE CUSTOMER REPORTED THAT "THE SPO2 VALUES MEASURED BY THE MONITOR ARE 'FALSELY' LOW COMPARED WITH THE CLINICAL SIGNS AND BLOOD GAS RESULTS, AND WHEN COMPARED WITH OTHER PULSE OXIMETERS". "THE DELTA OBSERVED COULD VARY FROM 2 TO 15 PTS VERSUS OTHER PULSE OXIMETERS". "THIS HAS LED TO UNNECESSARY OXYGEN TREATMENT" WITH NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24397485 ↗
• MalfunctionFeb 19, 2026Low Readings

  THE CUSTOMER REPORTED THAT "THE SPO2 VALUES MEASURED BY THE MONITOR ARE 'FALSELY' LOW COMPARED WITH THE CLINICAL SIGNS AND BLOOD GAS RESULTS, AND WHEN COMPARED WITH OTHER PULSE OXIMETERS". "THE DELTA OBSERVED COULD VARY FROM 2 TO 15 PTS VERSUS OTHER PULSE OXIMETERS". "THIS HAS LED TO UNNECESSARY OXYGEN TREATMENT" WITH NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24397462 ↗
• MalfunctionFeb 19, 2026Low Readings

  THE CUSTOMER REPORTED THAT "THE SPO2 VALUES MEASURED BY THE MONITOR ARE 'FALSELY' LOW COMPARED WITH THE CLINICAL SIGNS AND BLOOD GAS RESULTS, AND WHEN COMPARED WITH OTHER PULSE OXIMETERS". "THE DELTA OBSERVED COULD VARY FROM 2 TO 15 PTS VERSUS OTHER PULSE OXIMETERS". "THIS HAS LED TO UNNECESSARY OXYGEN TREATMENT" WITH NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24397390 ↗
• MalfunctionDec 31, 2025Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED "THE SENSOR STOPPED WORKING WHEN THE PATIENT WAS CONNECTED, BUT THERE WAS NO BREAKAGE ON THE DEVICE. THIS TYPE OF SENSOR HAS A HIGHER IMPEDANCE, RESULTING IN A SATURATION READING APPROXIMATELY 8-10 POINTS LOWER THAN ARTERIAL BLOOD GAS ANALYSIS. THIS HAS BEEN REPORTED SEVERAL TIMES BY MY TEAM. THE PERFUSION SIGNAL IS ABOVE 1, INDICATING A GOOD SIGNAL AND WAVEFORM." "THE CLINICIANS OBSERVED A SIGNIFICANT DISCREPANCY BETWEEN THE BLOOD GAS MEASUREMENT AND THE SPO2 MEASUREMENT." THE SPO2 MEASUREMENT FROM THE SENSOR WAS 99% AND THE ABG SO2 MEASUREMENT WAS 83.7%. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23936830 ↗
• MalfunctionDec 31, 2025Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED "THE SENSOR STOPPED WORKING WHEN THE PATIENT WAS CONNECTED, BUT THERE WAS NO BREAKAGE ON THE DEVICE. THIS TYPE OF SENSOR HAS A HIGHER IMPEDANCE, RESULTING IN A SATURATION READING APPROXIMATELY 8-10 POINTS LOWER THAN ARTERIAL BLOOD GAS ANALYSIS. THIS HAS BEEN REPORTED SEVERAL TIMES BY MY TEAM. THE PERFUSION SIGNAL IS ABOVE 1, INDICATING A GOOD SIGNAL AND WAVEFORM." "THE CLINICIANS OBSERVED A SIGNIFICANT DISCREPANCY BETWEEN THE BLOOD GAS MEASUREMENT AND THE SPO2 MEASUREMENT." THE SPO2 MEASUREMENT FROM THE SENSOR WAS 99% AND THE ABG SO2 MEASUREMENT WAS 83.7%. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23936813 ↗
• MalfunctionMar 26, 2025No Apparent Adverse Event; No Apparent Adverse Event

  PER MEDWATCH REPORT (B)(4), THE CUSTOMER REPORTED THAT THE SENSOR "WAS READING SENSOR MALFUNCTION OFF AND ON THROUGHOUT THE DAY WITH LARGE VARIATIONS IN OXYGEN SATURATION AT TIMES THAT WOULD QUICKLY RESOLVE". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21699128 ↗
• MalfunctionNov 26, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  PER MEDWATCH (B)(4): THE CUSTOMER REPORTED THAT THE SENSOR "ADHESIVE WAS TOO SHORT TO FIT [THE PATIENT'S] HAND/WRIST". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20782898 ↗
• MalfunctionNov 26, 2024Unable to Obtain Readings; Patient-Device Incompatibility; Unable to Obtain Readings; Patient-Device Incompatibility

  PER MEDWATCH (B)(4): THE CUSTOMER REPORTED THAT THE SENSOR "WAS NOT ABLE TO GET A GOOD PLETHYSMOGRAPH READING," WITH "DIFFICULTY GETTING THE PROBE TO STAY ON HIS HAND." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20781226 ↗
• MalfunctionNov 25, 2024Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED THAT THE SENSOR "WAS WORKING ON INTERMITTENTLY", WHERE IT "FAILED TO READ. PULSE OXIMETER WAS REPOSITIONED SEVERAL TIMES WITHOUT SUCCESSFUL RETURN TO FUNCTION...UNABLE TO ESTABLISH A CONSISTENT, RELIABLE, AND ACCURATE PULSE OXIMETER READING". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20774742 ↗
• MalfunctionOct 3, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

  PER MEDWATCH (B)(4) THE CUSTOMER REPORTED THAT THE "PATIENT'S MONITOR SAID THAT THE PULSE OXIMETER WAS OFF PATIENT. THE SENSOR WAS STILL ON THE PATIENT AND EVERYTHING WAS CONNECTED." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20363886 ↗

Other Masimo Corporation products

• RAD-G4 models · 194 reports · 4 recalls
• Rad-973 models · 330 reports
• Rad-8 Horizontal Signal Extraction Pulse Oximeter2 models · 123 reports
• Radius VSM7 models · 13 reports · 2 recalls
• Rad-5 Handheld signal extraction pulse oximeter2 models · 76 reports
• LNCS-II rainbow2 models · 1 reports · 1 recall
• Rad-5v Handheld signal extraction pulse oximeter2 models · 46 reports
• Radius-73 models · 35 reports