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.
Enforcement
- Recall Number
- Z-0416-2026
- Event ID
- 97686
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Spacelabs Healthcare, Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 12, 2025
- Initiation Date
- September 16, 2025
- Classification Date
- October 31, 2025
- Address
- Unit B, Foxholes Centre; John Tate Road, Hertford, N/A, N/A, United Kingdom
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.
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
Catalog Number: 92810 UDI-DI code; (01)10841522125751 Software version: 11.6.0
Worldwide - US Nationwide distribution in the state of MN and the countries of CA, DE, FR, GB, IT, NC.
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