Radius VSM 9037Recalls & reported problems
Masimo Corporation · Radius VSM Patient-Worn Vital Signs Monitor, 1/Box · Class 2
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00843997019163), received between Mar 14, 2026 and Sep 4, 2026 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (5 reports).
2 other recalls cover devices cleared under the same FDA submission (K223498); 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.
Reports received per month
Most reported problems
Device problems
- Incorrect Measurement5
- Low Readings5
- No Audible Alarm2
- No Display/Image2
- Sensing Intermittently2
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Insufficient Information3
- Arrhythmia1
Recent adverse event reports
The 10 most recent of 10 reports, 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 ↗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 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K223498. One submission often covers many models, so check the product and lot details in each record.
- Z-2671-2026 · Feb 20, 2026 · Open, ClassifiedRadius VSM Disposable NIBP Cuff, REF: 4825, 4826
- Z-2670-2026 · Feb 20, 2026 · Open, ClassifiedRadius VSM ECG pre-connected Set, REF: 4842, 4695
Other MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) devices
- IntelliVue MX40 1.4GHz MX40 1.4 GHz Smart HoppingPhilips Medical Systems Hsg · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall47 deaths2,541 reports
- NA PU-621RNihon Kohden Corporation · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)17 deaths1,666 reports
- Tempus Pro 00-1024-RRemote Diagnostic Technologies Limited · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)7 recalls8 deaths1,217 reports
- NA PU-681RANihon Kohden Corporation · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)22 deaths1,493 reports
- IntelliVue Multi-Measurement Module X3 IntelliVue X3Philips Medizin Systeme Böblingen GmbH · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall19 deaths1,172 reports
- Patient Information Center IXPhilips Medical Systems Hsg · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)82 deaths941 reports
- Patient Information Center iXPhilips Medical Systems Hsg · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)83 deaths814 reports
- Tempus Pro 00-1024-RRemote Diagnostic Technologies Limited · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)5 recalls541 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.