Medical DeviceView official recall notice →
Radius VSM Disposable NIBP Cuff, REF: 4825, 4826
Brand / Firm
Product
Radius VSM Disposable NIBP Cuff, REF: 4825, 4826
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
1,028
Description
Radius VSM Disposable NIBP Cuff, REF: 4825, 4826