Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product Descrip
FDA device recall Z-0416-2026 · posted 2025-10-31 · Open, Classified
Recall details
- Recalling firm
- Spacelabs Healthcare, Ltd.
- 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
- 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.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- DQK
- Quantity affected
- 142
- Distribution
- Worldwide - US Nationwide distribution in the state of MN and the countries of CA, DE, FR, GB, IT, NC.
- Date initiated
- 2025-09-16
- Date posted
- 2025-10-31
- Location
- Hertford, United Kingdom
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM (K152881) | Spacelabs Healthcare, Ltd. | 2016-04-01 |