Spacelabs Healthcare, Ltd. recalls Brand Name: Sentinel V11 Product Name: Sentinel V11
- Recalling company
- 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
- 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 – may cause temporary or medically reversible health consequences
- Recall date
- Sep 16, 2025
- Reported
- Nov 12, 2025
- Distribution
- Worldwide - US Nationwide distribution in the state of MN and the countries of CA, DE, FR, GB, IT, NC.
- Status
- Ongoing
- Quantity
- 142
- Lot / codes
- Catalog Number: 92810 UDI-DI code; (01)10841522125751 Software version: 11.6.0
- Company location
- Hertford, N/A
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0416-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0416-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.