Brand Name: Sentinel V11 Product Name: Sentinel V11 recall
Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product Description: Cardiology Information…
Why was Brand Name: Sentinel V11 Product Name: Sentinel V11 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
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog Number: 92810 UDI-DI code; (01)10841522125751 Software version: 11.6.0
- Product
- Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product Description: Cardiology Information…
- Recalling firm
- Spacelabs Healthcare, Ltd.
- Quantity
- 142
- Distribution
- Worldwide - US Nationwide distribution in the state of MN and the countries of CA, DE, FR, GB, IT, NC.
- Recall date
- November 12, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)