FRED easy Defibrillators manufactured by Schiller.
All devices are affected.
Devices are distributed by Amazon Medical Ltd.
Affected defibrillators:
NOTE: FRED easyport is not affected
Product All models
Article number
FRED easy Basic
REF BR-FREDEASY
FRED easy ECG on-screen
REF BR-FREDEE
FRED easy Manual
REF BR-FREDEEM
Teligen implantable cardioverter defibrillators (ICDs) and Cognis cardiac resynchronisation therapy defibrillators (CRT-Ds) – specific models.
Manufactured by Boston Scientific.Models affected by this alert:Teligen ICDs model numbers E102, E110, E111, F102, F110 and F111.
Cognis CRT-Ds model numbers N106, N107, N108, N118, N119, P106, P107 and P108.
TELIGENTM implantable cardioverter defibrillators (ICD) and COGNISTM cardiac resynchronisation therapy devices (CRT-D) manufactured by Boston Scientific.The manufacturer has issued a Field Safety Notice (400Kb) (FSN) in relation to the second subset of affected devices. This notice has been distributed to clinics that have implanted these devices and conduct routine patient follow-up, and also to clinics equipped with compatible programmers.Device family
Affected model numbers
COGNIS CRT-D
N106/N107/N118/N119/P106/P107/P108
TELIGEN DR ICD
E110/F110/F111
TELIGEN VR ICD
E102/F102/F103You can check specific device–serial number combinations to find out if they are affected. This look-up tool differentiates newly identified devices from those already subject to the 2013 advisory notice.