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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Biotronik Inc
Lot Codes / Batch Numbers
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
Products Sold
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
Biotronik Inc is recalling Lumax Cardiac Resyncronization Therapy Defibrillator (CRT-D); Implantable, dual-chamber defibrillato due to 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.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026