Recall Z-1373-2008 ยท MRM Defibrillator, Implantable, Dual-Chamber
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.
| Date | Jul 29, 2008 (initiated Jan 10, 2007) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.