Radius VSMRecalls & reported problems across all models
Masimo Corporation · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Radius VSM model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 2
We found 7 models of Radius VSM by Masimo Corporation in the FDA's device registry (GUDID). Together they are named in 13 adverse event reports in the FDA's MAUDE database, received between Feb 5, 2026 and Sep 4, 2026 — classified as 13 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (5 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 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
Reports received per month, all models
Radius VSM 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.
- Feb 20, 2026Open, Classified
Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could delay treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness.
Z-2671-2026 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗
- Feb 20, 2026Open, Classified
Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could delay treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness.
Z-2670-2026 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗
Most reported Radius VSM problems
Device problems
- Incorrect Measurement5
- Low Readings5
- High Readings2
- No Audible Alarm2
- No Display/Image2
- Sensing Intermittently2
- Device Alarm System1
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Insufficient Information3
- Arrhythmia2
Radius VSM models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Radius VSM 4825blood pressure cuff1 recall0 reports
- Radius VSM 4826blood pressure cuff1 recall0 reports
- Radius VSM 4842Electrocardiograph1 recall0 reports
- Radius VSM 4695Electrocardiograph1 recall0 reports
- Radius VSM 9037MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)10 reports
- Radius VSM 9033MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)2 reports
- Radius VSM 4888Electrocardiograph1 report
Recent Radius VSM adverse event reports
The 13 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 4, 2026Incorrect Measurement; Low Readings
Patient problems: Insufficient Information
MAUDE report 50623631 ↗MalfunctionSep 4, 2026Incorrect Measurement; Low Readings
Patient problems: Insufficient Information
MAUDE report 50623485 ↗MalfunctionSep 4, 2026Incorrect Measurement; Low Readings
Patient problems: Insufficient Information
MAUDE report 50623099 ↗MalfunctionSep 2, 2026Incorrect Measurement; Low Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50568958 ↗MalfunctionSep 1, 2026Incorrect Measurement
Patient problems: Arrhythmia
MAUDE report 50554210 ↗MalfunctionSep 1, 2026Incorrect, Inadequate or Imprecise Result or Readings; Low Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50554204 ↗MalfunctionSep 1, 2026High Readings
Patient problems: Arrhythmia
MAUDE report 50536287 ↗MalfunctionMar 16, 2026No Audible Alarm
THE CUSTOMER REPORTED THE RADIUS VSMS "FAILS TO ALARM LOW BATTERY." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24613977 ↗MalfunctionMar 16, 2026No Audible Alarm
THE CUSTOMER REPORTED THE RADIUS VSMS "FAILS TO ALARM LOW BATTERY." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24613952 ↗MalfunctionMar 14, 2026No Display/Image; Sensing Intermittently
THE CUSTOMER REPORTED THE DISAPPEARANCE "OF TEMPERATURE AND NIBP MEASUREMENT" ON THE RADIUS VSMS. MEASUREMENTS FROM THE VSM SHOWED UP BLANK ON THE PSN AND THERE WAS NO ERROR NOR ALARM TRIGGERED. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24601451 ↗MalfunctionMar 14, 2026No Display/Image; Sensing Intermittently
THE CUSTOMER REPORTED THE DISAPPEARANCE "OF TEMPERATURE AND NIBP MEASUREMENT" ON THE RADIUS VSMS. MEASUREMENTS FROM THE VSM SHOWED UP BLANK ON THE PSN AND THERE WAS NO ERROR NOR ALARM TRIGGERED. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24601448 ↗MalfunctionFeb 17, 2026High Readings
THE CUSTOMER REPORTED THAT THE PATIENT HAD A HEART RATE OF 240 PER THE MASIMO DEVICE BUT THE ACTUAL HEART RATE IS IN 70S. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24373844 ↗MalfunctionFeb 5, 2026Device Alarm System
THE CUSTOMER REPORTED THAT "AFIB ALARMS NOT PERFORMING AS EXPECTED. INAPPROPRIATE EXTREME BRADY/TACHY ALARMS IN ATRIAL FIBRILLATION AND FALSE ATRIAL FIBRILLATION ALARMS DURING SINUS RHYTHM WITH ECTOPIC BEATS". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24274968 ↗
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
- RD SET12 models · 49 reports · 1 recall
- 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
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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