FDA-Device2025-11-12Class II
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.
Spacelabs Healthcare, Ltd.
Hazard
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
Sold states
Worldwide - US Nationwide distribution in the state of MN and the countries of CA, DE, FR, GB, IT, NC.
Affected count
142
Manufactured in
Unit B, Foxholes Centre; John Tate Road, Hertford, N/A, United Kingdom
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0416-2026Don't want to check this manually?
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