—#218630

Product

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 4.0.2 / 10884521856134 The Vital Sync" Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Virtual Patient Monitoring Platform, 3rd Party Annunciation Systems, Electronic Medical Record (EMR) and Clinical Information System (CIS).

FDA product code: MWI — Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K160718
Affected lot / code info: HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: CFN: VSLBASE03P / VITALSYNCSW03 UDI-DI (GTIN); 10884521844933 Serial Number: Vital Sync 3.3.1 CFN: VSLBASE03P / VITALSYNCSW03 UDI-DI (GTIN): 10884521844940 Serial Number: Vital Sync 3.4.0 CFN: VSLBASE03P / VITALSYNCSW03 (OUS only) UDI-DI (GTIN): 10884521847569 Serial Number: Vital Sync 3.4.1 CFN: VSLBASE03P / VITALSYNCSW03 UDI-DI (GTIN): 10884521856127 Serial Number: Vital Sync 3.4.2 CFN: VSLBASE04P / VITALSYNCSW04 UDI-DI (GTIN): 10884521849358 Serial Number: Vital Sync 4.0.1 CFN: VSLBASE04P / VITALSYNCSW04 UDI-DI (GTIN): 10884521856134 Serial Number: Vital Sync 4.0.2

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Covidien LLC
Address: 6135 Gunbarrel Ave, Boulder, Colorado 80301-3214

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2026-01-30
Posted by FDA: 2026-03-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #218630. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.