FDA-Device2026-07-08Class II
Radius VSM ECG pre-connected Set, REF: 4842, 4695
Hazard
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.
Sold states
Worldwide - US Nationwide distribution in the states of OK, CA , MD , MA , NY , UT , NC , TN , MN , TX , OH , PA , VA and the countries of Italy, Latvia, Iraq, Saudi Arabia, Germany, Spain, Turkey, France, Australia, Malta, Oman, United Arab Emirates, Martinique, Netherlands, Cyprus, Kuwait, Czech Republic, United Kingdom, Croatia, Switzerland, Belgium, Singapore, Romania, Colombia, Hong Kong, Israel, Finland, Poland, New Zealand, Tunisia, Chile, Algeria, Canada, Denmark, Palestinian Territory, Qatar, Greece, Paraguay.
Affected count
772
Manufactured in
52 Discovery, N/A, Irvine, CA, United States
Products
Radius VSM ECG pre-connected Set, REF: 4842, 4695
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2670-2026More Masimo Corporation recalls
- FDA-Device2026-07-08Radius VSM Disposable NIBP Cuff, REF: 4825, 4826
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