Reported Nov 12, 2025 · Ongoing
Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product…
Spacelabs Healthcare, Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Spacelabs Healthcare, Ltd. · Unit B · Hertford, N/A · N/A
Is this the product you have?
- Brand NameSentinel
- V11 Product NameSentinel
- V11 Model/Catalog Number92810
- Software Version11.6.0
- Product DescriptionCardiology
- Information Management System ComponentNo 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 codes and dates
- Catalog Number
92810 UDI-DI code(01)10841522125751
- Software version11.6.0
- Catalog Number
- Amount recalled
- 142
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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