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Recall Observatory FDA recall evidence

Device 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.

Z-0416-2026

September 16, 2025

Class II

Product summary

Firm
Spacelabs Healthcare, Ltd.
Event
Event 97686
Status
Ongoing
Classification
Class II
Quantity
142
Official record key
device-enforcement:Z-0416-2026

Official wording

Reason: 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

Code information: Catalog Number: 92810 UDI-DI code; (01)10841522125751 Software version: 11.6.0

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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