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Brand Name: Sentinel V11 recallZ-0416-2026 · Spacelabs Healthcare, Ltd. · initiated Sep 16, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Spacelabs Healthcare, Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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

FDA root cause category: Software design

What the company is doing

On 09/15/2025, the firm sent via email an "URGENT MEDICAL DEVICE CORRECTION" Letter to customer informing them of two issues associated with the Sentinel Software Version 11.6.0. The issues are: 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. Customers are instructed to: 1. Print and Post Notification: Please print the related Urgent User Notification (Appendix A) in all location(s) where Sentinel 11.6.0 is used to configure ABP and/or Ambulatory ECG (Holter) devices. 2. Notify all relevant employees within their organization, including satellites, of this recall 3. Confirm the above action has been taken: Go to the QR code below (Appendix B) and confirm that they have read, understood, and posted the user notification at their workstations. 4. Contact Customer Support team at [email protected] with any questions regarding this identified issue. A fix for these issues is being developed, and is anticipated to be available by the end of September 2025. A Spacelabs Healthcare representative will notify customers once the fix is available and will work with customers to schedule the software update. Note, rolling back Sentinel 11.6.0 to a previous version is not a valid option.

Recall details

Recall number
Z-0416-2026
Status
Open, Classified
Initiated by the company
Sep 16, 2025
Posted by the FDA
Oct 31, 2025
Recalling firm
Spacelabs Healthcare, Ltd.
Quantity
142
Product code
DQK
FDA submissions
K152881
Distribution
Worldwide - US Nationwide distribution in the state of MN and the countries of CA, DE, FR, GB, IT, NC.

Product description

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.

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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