Spacelabs Healthcare, Ltd.: Medical Device Recall in 2025 - (Recall #: Z-0416-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product Description: Cardiology Information Management System Component: No The Sentinel Cardiology Information Management System is intended to connect to supported medical devices and analyzers in order to download, store, access and manage cardiovascular information and to manage patient and facility information.

Product Classification:

Class II

Date Initiated: September 16, 2025

Date Posted: November 12, 2025

Recall Number: Z-0416-2026

Event ID: 97686

Reason for Recall:

Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of a previously viewed patient. 2. Systems configured with Resting/Rhythm ECG functionality, under specific navigation conditions, test data intended for one patient may be saved under another patient's record

Status: Ongoing

Product Quantity: 142

Code Information:

Catalog Number: 92810 UDI-DI code; (01)10841522125751 Software version: 11.6.0

Distribution Pattern:

Worldwide - US Nationwide distribution in the state of MN and the countries of CA, DE, FR, GB, IT, NC.

Voluntary or Mandated:

Voluntary: Firm initiated