United StatesSentinel V11 Cardiology Information Management System (Brand Name: Sentinel V11, Catalog/Model 92810, Software version 11.6.0, UDI-DI (01)10841522125751) is being recalled; units were distributed worldwide including the U.S. (MN) and CA, DE, FR, GB, IT, NC. It was recalled because patient demographic fields may default to a previously viewed patient during admission, and, under specific navigation conditions on systems with Resting/Rhythm ECG functionality, test data intended for one patient may be saved under another patient’s record.
What's being recalled
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.
Recalling firm: Spacelabs Healthcare, Ltd., Hertford, N/A, United Kingdom.
How to identify it
Catalog Number: 92810 UDI-DI code; (01)10841522125751 Software version: 11.6.0
The hazard
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
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide - US Nationwide distribution in the state of MN and the countries of CA, DE, FR, GB, IT, NC.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)