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.
From the FDA notice · Read the official notice ↗ · All Spacelabs Healthcare recalls
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- 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.
- Sold in
- Nationwide
- Made for
- All ages (under 120 years)
Details
- Units affected
- 142
- Illnesses reported
- None reported
- Manufactured in
- Unit B, Foxholes Centre; John Tate Road, Hertford, N/A, United Kingdom
- Classification
- Class II
- Recall number
- Z-0416-2026
In the FDA's words
- 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 Distribution: Worldwide - US Nationwide distribution in the state of MN and the countries of CA, DE, FR, GB, IT, NC. Affected quantity: 142
- 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