Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog… — Class II medical device recall Z-0416-2026
Ongoing recall by Spacelabs Healthcare, Ltd., reported 2025-11-12, distributed nationwide. Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of a
| Recall number | Z-0416-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spacelabs Healthcare, Ltd., Hertford, N/A, United Kingdom |
| Recall initiated | 2025-09-16 |
| Classified | 2025-10-31 |
| Reported by FDA | 2025-11-12 |
| Distributed | Nationwide (US) |
| Quantity | 142 |
| UPC / GTIN / UDI-DI | 10841522125751 |
| Model numbers | 92810 |
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 for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0416-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.