Recall Z-2670-2026 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Masimo Corporation
Radius VSM ECG pre-connected Set, REF: 4842, 4695
| Date | Jul 2, 2026 (initiated Feb 20, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | On 2/20/2026 / 3/4/3036 recall notices/updated notices were mailed to customers who were asked to do the following: 1) Always pay attention to alerts and alarms displayed and post this notice as a constant reminder for those using the devices. 2) Post this notification as a constant reminder for anyone using the devices. 3) If you wish to return the impacted devices, please contact the firm's Technical Services; see email below. 4) Complete the bottom portion of the notice and return via email to CustomerNotice@masimo.com Customer Care is available at 1-800-916-1270 for US customers Monday t |
| Quantity | 772 |
| Distribution | 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 R |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223498 | Radius VSM and Accessories Masimo Corporation, Jun 1, 2023 |