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Vital Sync recallZ-1557-2026 · Covidien LLC · initiated Jan 30, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Covidien LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-1557-2026
Status
Open, Classified
Initiated by the company
Jan 30, 2026
Posted by the FDA
Mar 11, 2026
Recalling firm
Covidien LLC
Quantity
78 systems
Product code
MWI
FDA submissions
K160718
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.

Product description

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).

Code information (models, lots, serial numbers)

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

Devices named in this recall

6 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

3 devices cleared under K160718 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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