Spacelabs Healthcare, Ltd. recalls Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Soft…

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

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.

• FDA enforcement recordOfficial FDA database entry for Z-0416-2026
• FDA 510(k) clearance · K152881The device's official FDA premarket clearance record
• FDA device classification · DQKOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.1425The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Spacelabs Healthcare, Ltd.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.