Inc, Cl Ill Biotronik

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

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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