Recall Z-0416-2026 ยท DQK Computer, Diagnostic, Programmable
Spacelabs Healthcare, Ltd.
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 an
| Date | Oct 31, 2025 (initiated Sep 16, 2025) |
| Status | Open, Classified |
| Reason | 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 | 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 (Ap |
| Quantity | 142 |
| Distribution | Worldwide - US Nationwide distribution in the state of MN and the countries of CA, DE, FR, GB, IT, NC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152881 | SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM Spacelabs Healthcare, Ltd., Apr 1, 2016 |