|
Class 2 Device Recall Tachos |
|
Date Initiated by Firm |
April 29, 2004 |
Date Posted |
July 20, 2004 |
Recall Status1 |
Terminated 3 on April 21, 2006 |
Recall Number |
Z-0941-04 |
Recall Event ID |
28982 |
PMA Number |
P000009/S1 |
Product Classification |
Implantable Cardioverter Defibrillator (Non-Crt) - Product Code LWS
|
Product |
Tachos DR - Implantable Cardioverter Defibrillator |
Code Information |
Model Number 335 572 Serial numbers: 78011709 - 78011712, 78011714 ¿ 78011719, 78011725 ¿ 78011729, 78011759 ¿ 78011763, 78011769 ¿ 78011778, 78011780 ¿ 78011791, 78011793 - 78011829, 78011831, 78011833 ¿ 78011864, 78011866 ¿ 78011928, 78011930 ¿ 78011937, 78011939 ¿ 78011949, 78011951 ¿ 78011981, 78011983 ¿ 78011985, 78011987 ¿ 78011988, 78019000 -78019014, 78019016 ¿ 78019025, 78019027, 78019029 ¿ 78019035, 78019037 ¿ 78019051, 78019053 ¿ 78019066, 78019068 ¿ 78019081, 78019083, 78019084, 78019086 ¿ 78019091, 78019096 ¿ 78019099, 78019101 ¿ 78019105, 78019107 ¿ 780190122, 78019126 ¿ 780190129, 78019131 ¿ 78019140 |
Recalling Firm/ Manufacturer |
Biotronik Inc 6024 Jean Rd Lake Oswego OR 97035-5308
|
For Additional Information Contact |
Jon Brumbaugh 888-345-0374
|
Manufacturer Reason for Recall |
Potential for device to not deliver full amount of energy
|
FDA Determined Cause 2 |
Other |
Action |
On 4/29/04 the firm issued 'Dear Doctor' letters to the physicians. The letter instructs the physician to schedule an immediate follow-up with all affected patients to determine if their devices are being impacted by the passivation buildup and to determine if device replacement is indicated. |
Quantity in Commerce |
363 |
Distribution |
Devices were distributed to physicians and medical centers throughout the U.S.
The firm does not distribute internationally. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
|
|
|