Spacelabs Healthcare, Ltd.: Device Recall

Recall Details

Recall Number

Z-0416-2026

Classification

Class II

Product Type

Device

Recalling Firm

Spacelabs Healthcare, Ltd.

Status

Ongoing

Date Initiated

09/16/2025

Location

Hertford, N/A, United Kingdom

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

142

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

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.

Distribution Pattern

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

Other Recalls by Spacelabs Healthcare, Ltd.

• Class II: Risk 11/25/2024
  Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter recorder. The physical serial number label on the device might not match the serial number programmed into the device.
• Class II: Risk 11/25/2024
  Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter recorder. The physical serial number label on the device might not match the serial number programmed into the device.

View all recalls by Spacelabs Healthcare, Ltd. →