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U.S. Department of Health and Human Services

Class 3 Device Recall Lumax Cardiac Resyncronization Therapy Defibrillator (CRTD)

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 Class 3 Recall
Lumax Cardiac Resyncronization Therapy Defibrillator (CRTD)
see related information
Date Posted July 29, 2008
Recall Status1 Open
Recall Number Z-1373-2008
Recall Event ID 46751
Premarket Approval
PMA Number
P050023/S006
Product Classification Defibrillator, Implantable, Dual-Chamber - Product Code MRM
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.
Code Information Software version 603.U, Catalog/Model Number: 359251; ICS 300 programmers Catalog/Model Numbers: 349527, 449530 and 355547; Lumax 340 HF-T Units, Catalog Number: 355263
Recalling Firm/
Manufacturer
Biotronik Inc
6024 Jean Rd
Lake Oswego, Oregon 97035-5308
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: Software Design
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.
Quantity in Commerce 53 of the 603.U discs distributed.
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = MRM and Applicant = BIOTRONIK, INC.
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