Rad-G YI Multisite Reusable Sensor 4653Recalls & reported problems
Masimo Corporation · Rad-G YI Multisite Reusable Sensor · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843997015530), received between Feb 13, 2026 and Feb 13, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Sensing Intermittently” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K213676); 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Sensing Intermittently1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 13, 2026Sensing Intermittently
THE CUSTOMER REPORTED THAT "IT TOOK SEVERAL MINUTES FOR THE MACHINE TO TRY TO READ AFTER ATTACHING THE SENSOR TO THE PATIENT, AND ONCE IT DID, IT BEGAN READING ON AND OFF FOR SEVERAL MINUTES. THIS LAST OCCURRENCE, IT TOOK ME 10 MINUTES TO GET A READ, WITH MULTIPLE TIMES REBOOTING THE DEVICE. SENSOR IS READING 60% SPO2 AND 60 PR". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24338637 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K213676. One submission often covers many models, so check the product and lot details in each record.
- Z-1536-2024 · Feb 15, 2024 · Open, ClassifiedMasimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,
- Z-1539-2024 · Feb 15, 2024 · Open, ClassifiedMasimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only,
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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