# FDA recall Z-0416-2026

> **Spacelabs Healthcare, Ltd.** · Class II · device recall initiated 2025-09-16.

## 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

## Distribution

Worldwide - US Nationwide distribution in the state of MN and the countries of CA, DE, FR, GB, IT, NC.

## Key facts

- **Recall number:** Z-0416-2026
- **Recalling firm:** Spacelabs Healthcare, Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-16
- **Report date:** 2025-11-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hertford, N/A, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0416-2026

## Citation

> AI Analytics. FDA recall Z-0416-2026. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0416-2026. Source: US FDA. Licensed CC0.

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