Masimo Radius VSM ECG pre-connected Set recalled for false heart rate alarms and cuff skin irritation
What this means
Masimo Corporation recalled its Radius VSM ECG pre-connected Set due to two issues: the ECG electrode assembly may incorrectly detect abnormal heart rhythms in patients with normal heart rates, triggering false alarms that can distract clinicians from real patient concerns; and small and medium blood pressure cuffs may have rough edges that can irritate skin.
- If you use this device in a hospital or clinic, contact your Masimo representative or facility biomedical engineering team.
- Do not rely on ECG alarms alone for patient assessment; verify readings with clinical observation.
- Inspect blood pressure cuffs for rough edges before use; discontinue use if irritation occurs.
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2670-2026More Masimo Corporation recalls
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