Important Safety Alerts

Important Safety Alerts

Field Safety Notice: Boston Scientific ICD TELIGEN, Model Nos.: F102, F103, F110, F111 and CRT-D COGNIS, Model Nos.: P107 and P108

14 Mar 2012

It comes to our attention that the State Institute for Drug Control, Czech Republic received information from Boston Scientific that the below Implantable cardioverter-defibrillator (ICD) and Defibrillator for cardiac resynchronization therapy (CRT-D) were stolen from the service car of clinical engineer on March 01, 2012 in the territory of the Czech Republic.

Caption: Implantable cardioverter-defibrillator (ICD) and Defibrillator
Trade Name Model No. Material No. Serial No. Expiration Date
ICD TELIGEN_HE VR DF1 F102 60F102-814 113139 4.8.2012
ICD TELIGEN_HE VR DF1 F102 60F102-814 114621 9.12.2012
ICD TELIGEN_HE VR DF4 F103 60F103-805 116879 16.12.2012
ICD TELIGEN_HE DR DF1 F110 60F110-814 117249 10.8.2012
ICD TELIGEN_HE DR DF4 F111 60F111-805 104766 6.7.2012
ICD TELIGEN_HE DR DF4 F111 60F111-805 104769 6.7.2012
CRT-D COGNIS_HE DF1/IS1 P107 60P107-814 113354 14.5.2012
CRT-D COGNIS_HE DF1/IS1 P107 60P107-814 115530 29.7.2012
CRT-D COGNIS_HE DF4 P108 60P108-805 107564 4.10.2012
CRT-D COGNIS_HE DF4 P108 60P108-805 107572 4.10.2012
CRT-D COGNIS_HE DF4 P108 60P108-805 107921 10.11.2012

If you are in possession of the affected product, please contact Boston Scientific for necessary actions.

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