Z-1373-2008

Lumax Cardiac Resyncronization Therapy Defibrillator (CRT-D); Implantable, dual-chamber defibrillator; Model...

Name: Z-1373-2008 Lumax Cardiac Resyncronization Therapy Defibrillator (CRT-D); Implantable, dual-chamber defibrillator; Model...
Creator: Biotronik Inc
Published: 2007-01-10
License: https://open.fda.gov/license/

BIOTRONIK AG / initiated 2007-01-10 / Terminated / root cause: software

FDA source

Biotronik Inc began a recall of Lumax Cardiac Resyncronization Therapy Defibrillator (CRT-D); Implantable, dual-chamber defibrillator; Model Number: HF-T; Catalog Number 355263; Software... on 2007-01-10. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1373-2008
Status: Terminated
Initiated: 2007-01-10
Posted: 2008-07-29
Terminated: 2011-05-05
Recalling firm: BIOTRONIK AG
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.
Product code: MRM Defibrillator, Implantable, Dual-Chamber
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.
Root cause tag: software
FDA 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 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.
Product codes and 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

Product code MRM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)