RD SET 4473Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10843997013229), received between Feb 19, 2026 and Sep 28, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Low Readings” (3 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

Recent adverse event reports

The 4 most recent of 4 reports, 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 ↗
• 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 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 24397462 ↗