FDA Medical Device Recalls (openFDA)
Biotronik Inc: 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 number
- Z-1373-2008
- Recalling firm
- Biotronik Inc
- 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.
- Status
- Terminated
- Initiated
- 2007-01-10
- Posted
- 2008-07-29
- Terminated
- 2011-05-05
- 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.
- Root cause
- 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
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- ["P050023S001","P050023S006"]
- Product code
- MRM
- Firm FEI
- 1028232
- Firm city
- Lake Oswego
- Firm state
- OR
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28