RD SET 4013Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10843997009659), received between Jan 25, 2019 and Nov 26, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Low Readings” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K180046); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionMay 1, 2024Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED ON THE MEDWATCH REPORT "PULSE OXIMETER FLATLINED ON MONITOR. NOTICED ON CENTRAL MONITOR BUT DID NOT ALARM. WENT INTO ROOM AND BABY WAS RESTING COMFORTABLY. SATURATION MONITOR WAS STILL ON FOOT AND PROPERLY POSITIONED." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19222664 ↗
• MalfunctionSep 20, 2023Unable to Obtain Readings; Unable to Obtain Readings

  THE CUSTOMER REPORTED THEY WERE UNABLE TO GET AN OXYGEN SATURATION READING FOR APPROXIMATELY 3 MINUTES FOLLOWING DELIVERY. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17786428 ↗
• MalfunctionApr 27, 2023Low Readings; Low Readings

  THE CUSTOMER REPORTED THE SENSOR APPEARS TO READ INACCURATELY LOW SATURATION AT TIMES. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16828505 ↗
• MalfunctionJan 25, 2019Low Readings; Low Readings

  THE CUSTOMER REPORTED THE RD NEWBORN SENSOR IS NOT GIVING ACCURATE VALUES. PHILIPS X3 SP05 (RD NEWBORN SENSOR): HAD FIRST VALUE: 70%, LAST VALUE: 85%. PHILIPS X2 FAST (FAST PEDIATRIC ADHESIVE SENSOR): FIRST VALUE 80%, LAST VALUE 95%. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8279445 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K180046. One submission often covers many models, so check the product and lot details in each record.

• Z-1983-2023 · Apr 21, 2023 · Open, Classified
  Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053