Recall Z-1373-2008
Biotronik Inc · initiated January 10, 2007
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.
Codes / lots: 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
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: Software design
Action taken
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.
Details
- Recall number
- Z-1373-2008
- Initiated
- January 10, 2007
- Posted by FDA
- July 29, 2008
- Terminated
- May 5, 2011
- Product code
- MRM – Defibrillator, Implantable, Dual-Chamber
- Quantity
- 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.
- Recalling firm
- Biotronik Inc, Lake Oswego, OR