Covidien LLC recalls HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Nu…

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.

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" bedside monitor. Customers are instructed to: "Notify all personnel in all care environments where RespArray" monitors are connected to Vital Sync"systems about this safety notice. "Post this notice in a prominent location and ensure awareness of the issue is maintained until the software update is installed. "If further distribution of RespArray" monitors that are connected to a Vital Sync" remote monitoring system to other facilities, promptly forward a copy of this letter to those recipients. Patient Management: For patients currently monitored by a RespArray" patient monitor and connected to the HealthCast" Vital Sync" remote monitoring system as an adjunct for patient monitoring, be advised that the SpO2 No Pulse, CO2 No Breath Detected and RESP No Breath Detected Alarm notifications from the primary RespArray" patient monitor are not transmitted to the Vital Sync" remote monitoring system. Refer to Clinical Discovery Guide for specific configurations selected by your facility. No additional action is required by treating clinicians other than recognition that the SpO2 No Pulse, CO2 No Breath Detected and RESP No Breath Detected Alarms are not available to be transmitted from the RespArray" monitor to the Vital Sync" remote monitoring system until after the updated software is installed. For question - contact Technical and Clinical Support at 800-255-6774, Option 6.

• FDA enforcement recordOfficial FDA database entry for Z-1557-2026
• FDA 510(k) clearance · K160718The device's official FDA premarket clearance record
• FDA device classification · MWIOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.2300The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Covidien LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.