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

FDA device recall Z-1373-2008 · posted 2008-07-29 · Terminated

Recall details

Recalling firm

Biotronik Inc

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.

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.

Root cause

Software design

Status

Terminated

Product code

MRM

Quantity affected

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.

Date initiated

2007-01-10

Date posted

2008-07-29

Date terminated

2011-05-05

Location

Lake Oswego, OR