Radius VSM 4888Recalls & reported problems
Masimo Corporation · Radius VSM Multi-functional Reusable Pod, 1/Box · Class 2
- 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 00843997009065), received between Sep 1, 2026 and Sep 1, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “High Readings” (1 report).
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
- High Readings1
Patient problems
- Arrhythmia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 1, 2026High Readings
Patient problems: Arrhythmia
MAUDE report 50536287 ↗
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-2670-2026 · Feb 20, 2026 · Open, ClassifiedRadius VSM ECG pre-connected Set, REF: 4842, 4695
- Z-2671-2026 · Feb 20, 2026 · Open, ClassifiedRadius VSM Disposable NIBP Cuff, REF: 4825, 4826
Other Electrocardiograph devices
- ELI 380 ELI380-DCS11Mortara Instrument, Inc. · Electrocardiograph1 recall1 death70 reports
- Cardiac Workstation Cardiac Workstation 7000Philips Medizin Systeme Böblingen GmbH · Electrocardiograph2 recalls17 reports
- Cardiac Workstation Cardiac Workstation 5000Philips Medizin Systeme Böblingen GmbH · Electrocardiograph2 recalls1 report
- MAC VU360GE Medical Systems Information Technologies, Inc. · Electrocardiograph2 recalls1 report
- Q-Stress QSERV-6AA-XXXXBMortara Instrument, Inc. · Electrocardiograph2 recalls1 report
- Welch Allyn, Inc. 901133Welch Allyn, Inc. · Electrocardiograph2 recalls0 reports
- Welch Allyn, Inc. 901133Welch Allyn, Inc. · Electrocardiograph2 recalls0 reports
- Q-Stress QS-6IA-AEDABMortara Instrument, Inc. · Electrocardiograph2 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.