Company: Biotronik, Inc
Date of Enforcement Report 8/6/2008
Class:lll

PRODUCT
Lumax Cardiac Resyncronization Therapy Defibrillator (CRT-D); Implantable, dual-chamber defibrillator; Model Number: HF-T; Catalog Number 355263; Software Version 603.U; Catalog Model Number 359251; ICS 3000 units are composed of three Catalog/Model Numbers: 349527, 349530, and 355547. The model 349530 is the component which is loaded/updated with software, Recall # Z-1373-2008

REASON
Timing Feature Error: An implementation error allows the usage of the V-V timing feature, which is not approved for use in the U.S.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Biotronik, Inc., Lake Oswego, OR, by letter on January 10, 2007.
Manufacturer: Biotronik Gmbh & Co, Berlin, Germany. Firm initiated recall is complete.

VOLUME OF PRODUCT IN COMMERCE
53 units

DISTRIBUTION
Nationwide