Spacelabs Healthcare, Ltd. recalls Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product Descri…

Recall date

September 16, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0416-2026

FDA classification

Class II

Brand / firm

Spacelabs Healthcare, Ltd.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.