Recall Z-0416-2026— Spacelabs Healthcare, Ltd.

Name: FDA recall Z-0416-2026
Creator: U.S. Food and Drug Administration
Published: 2025-09-16

Class II · Ongoing

Class II FDA medical device recall by Spacelabs Healthcare, Ltd., initiated 2025-09-16. It names one FDA 510(k) clearance: K152881. Product: 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.. Reason: 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.

Recalling firm: Spacelabs Healthcare, Ltd.
Classification: Class II
Status: Ongoing
Initiated: 2025-09-16
Firm location: Hertford, N/A, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K152881 — SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEMSpacelabs Healthcare, Ltd.·cleared 2016-04-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.