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 Compo

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

Details from the source

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 Distribution: Worldwide - US Nationwide distribution in the state of MN and the countries of CA, DE, FR, GB, IT, NC. Quantity: 142 Lot/code info: Catalog Number: 92810 UDI-DI code; (01)10841522125751 Software version: 11.6.0

UPC codes

10841522125751

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.