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.
FDA Recall Z-1373-2008 · Posted 2008-07-29
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Recalling FirmBiotronik Inc
Recall StatusTerminated
Product CodeMRM
Date Initiated2007-01-10
Date Terminated2011-05-05
Product Quantity53 of the 603.U discs distributed.
Reason for Recall
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.
Firm Action
Consignees were notified by a letter sent 1/10/07. The letter advised users to stop usage of the affected software. Users were instructed not to implant additional devices until the software program has been corrected. The recalling firm requested that all affected software be scrapped or returned to them. Users were requested update the software with a corrected version as soon as it becomes available.
Root Cause
Software design
Distribution Pattern
Nationwide Distribution including states of AL, AZ, CA, CO, DE, FL, GA, IL, LA, MI, MO, NC, NJ, NV, NY, OH, OR, PA, SC, TX and WA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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