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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-0943-04 |
Recall Event ID |
28982 |
PMA Number |
P0000000009 |
Product Classification |
Implantable Cardioverter Defibrillator (Non-Crt) - Product Code LWS
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Product |
Tachos ATx |
Code Information |
Model Number 334 342 Serial numbers: 78050083 ¿ 78050088, 78050091 ¿ 78050095, 78050097, 78050098, 78050100, 78050103 ¿ 78050105, 78050107, 78050109, 78050110, 78050113, 78050117 ¿ 78050122, 78050124 ¿ 78050128, 78050133 ¿ 78050139, 78050142 ¿ 78050144, 78050162 ¿ 78050169 |
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 |
50 |
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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