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Medical Device

Radius VSM ECG pre-connected Set, REF: 4842, 4695

Recall date: 2026-07-08 · Source: FDA_DEVICE
Brand / Firm
Masimo Corporation
Product
Radius VSM ECG pre-connected Set, REF: 4842, 4695
Reason for recall
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.
Units affected
772
Description
Radius VSM ECG pre-connected Set, REF: 4842, 4695
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