Spacelabs Healthcare, Ltd.: Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product Description: Cardiology
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Spacelabs Healthcare, Ltd.
- 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 / 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
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Worldwide - US Nationwide distribution in the state of MN and the countries of CA, DE, FR, GB, IT, NC.
- Recall initiated
- 2025-09-16
- Code info
- Catalog Number: 92810 UDI-DI code; (01)10841522125751 Software version: 11.6.0
- Product quantity
- 142
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Hertford
- State
- N/A
- Country
- United Kingdom
- Event id
- 97686
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