Recall Z-1557-2026 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Covidien LLC
HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital Sync 3.4.0 / 10884521844940 Vital Sync 3.4.1 / 10884521847569 (OUS Only) Vital Sync 3.4.2 / 10884521856127 Product Number: VSLBASE04P / VITALSYNCSW04 Model / UDI-DI codes: Vital Sync 4.0.0 / 10884521849358 Vital Sync 4
| Date | Mar 11, 2026 (initiated Jan 30, 2026) |
| Status | Open, Classified |
| Reason | Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system. |
| Root cause | Under Investigation by firm |
| Action | On 01/30/2026, the firm sent via mail or email an "Urgent Medical Device Correction" letter to customers informing them that based on a customer report determined that the SpO2 No Pulse Alarm was not transmitted to the Vital Sync" system as it was not properly configured in the system software. It was further identified that two additional alarms from RespArray" bedside monitors, CO2 No Breath Detected and RESP No Breath Detected Alarms, were not properly configured in the Vital Sync" system software. This issue only affects Vital Sync" remote patient monitoring system used with a RespArray" |
| Quantity | 78 systems |
| Distribution | Worldwide - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, FL, GA, IL, IN, KY, LA, MI, MN, MS, NC, NY, OH, OK, OR, SC, TN, TX, and VA. The country of Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160718 | Vital Sync Informatics Manager & Virtual Patient Monitoring Platform Covidien, Nov 14, 2016 |