Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product Des
Summary
The FDA issued a Class II for Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 9281 by Spacelabs Healthcare, Ltd.. Reason: Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of a previously viewed patient. 2. Systems.
Details
Source
Device Recall
External ID
Z-0416-2026
Action Date
2025-11-12
Status
Ongoing
Category
device
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.
Lot/Code Info: Catalog Number: 92810 UDI-DI code; (01)10841522125751 Software version: 11.6.0
Quantity Affected: 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
Distribution
Worldwide - US Nationwide distribution in the state of MN and the countries of CA, DE, FR, GB, IT, NC.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-16
Company
Hertford, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 185 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Spacelabs Healthcare, Ltd. has 5 FDA actions in our database, including 3 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Spacelabs Healthcare, Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Spacelabs Healthcare, Ltd. have FDA actions?
Spacelabs Healthcare, Ltd. has 5 FDA actions in our database, including 3 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0416-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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