Z-0416-2026Class II

Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0...

Name: Z-0416-2026 Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0...
Creator: Spacelabs Healthcare, Ltd.
Published: 2025-09-16
License: https://open.fda.gov/license/

GE Healthcare / initiated 2025-09-16 / Open, Classified / root cause: software

FDA source

Spacelabs Healthcare, Ltd. began a recall of Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product Description: Cardiology Information Management... on 2025-09-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0416-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-16
Posted: 2025-10-31
Recalling firm: GE Healthcare
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.
Product code: DQK Computer, Diagnostic, Programmable
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
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 142
Distribution: Worldwide - US Nationwide distribution in the state of MN and the countries of CA, DE, FR, GB, IT, NC.
Product codes and lots: Catalog Number: 92810 UDI-DI code; (01)10841522125751 Software version: 11.6.0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0416-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0416-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-12	2025-10-31

Product code DQK

K152881Class IISentinel Cardiology Information Management SystemSpacelabs Healthcare, Ltd. / cleared 2016-04-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)