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.
This recall is currently active, issued October 31, 2025. It was issued by Spacelabs Healthcare, Ltd. Unit B Foxholes Centre; John Tate Road Hertford United Kingdom.
- Recall Initiated
- September 16, 2025
- Posted
- October 31, 2025
- Recall Number
- Z-0416-2026
- Quantity
- 142
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Catalog Number: 92810 UDI-DI code; (01)10841522125751 Software version: 11.6.0
Root Cause
Software design
Action Taken
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 gtsdc@spacelabs.com 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.