Recall Z-0416-2026

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

FDA-determined 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.