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Class 2 Device Recall Tachos |
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Date Initiated by Firm |
April 29, 2004 |
Date Posted |
July 20, 2004 |
Recall Status1 |
Terminated 3 on April 21, 2006 |
Recall Number |
Z-0942-04 |
Recall Event ID |
28982 |
PMA Number |
P0000000009/ |
Product Classification |
Implantable Cardioverter Defibrillator (Non-Crt) - Product Code LWS
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Product |
Tachos DR - Atrial Tx |
Code Information |
Model Number 122 499 Serial numbers: 78012522, 78012524, 78012525, 78012548, 78012675, 78012677, 78012681, 78012683, 78012707, 78012709 ¿ 78012712, 78012714, 78012715, 78012718, 78012719, 78012763, 78012767, 78012768, 78012771, 78012791, 78012792, 78012794, 78012804, 78012809, 78012815 ¿ 78012820, 78012968, 78012987 ¿ 78012989, 78013072 ¿ 78013076, 78013092 ¿ 78013094, 78013099, 78013100, 78013165 ¿ 78013185, 78013194, 78013198, 78013200 ¿ 78013204, 78013206, 78013207, 78013210, 78013217 ¿ 78013220, 78013222, 78013224 ¿ 78013227, 78013230 ¿ 78013256, 78013258 ¿ 78013262, 78013278, 78013282, 78013284, 78013285, 78013292, 78013297, 78013299, 78013315, 78013317, 78013321 |
Recalling Firm/ Manufacturer |
Biotronik Inc 6024 Jean Rd Lake Oswego OR 97035-5308
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For Additional Information Contact |
Jon Brumbaugh 888-345-0374
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Manufacturer Reason for Recall |
Potential for device to not deliver full amount of energy
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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 |
128 |
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
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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.
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