FDAHealthSeptember 16, 2025
Spacelabs Healthcare, Ltd. — Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product Description: Cardiology Information Management System
⚠️ 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
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- September 16, 2025
Worldwide - US Nationwide distribution in the state of MN and the countries of CA, DE, FR, GB, IT, NC.
What's affected?
- 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.
- Lot code
- Catalog Number: 92810 UDI-DI code; (01)10841522125751 Software version: 11.6.0
Additional details
Catalog Number: 92810 UDI-DI code; (01)10841522125751 Software version: 11.6.0
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 142.
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