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U.S. Department of Health and Human Services

Class 2 Device Recall Tachos

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 Class 2 Device Recall Tachossee related information
Date Initiated by FirmApril 29, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on April 21, 2006
Recall NumberZ-0941-04
Recall Event ID 28982
PMA NumberP000009/S1 
Product Classification Implantable Cardioverter Defibrillator (Non-Crt) - Product Code LWS
ProductTachos 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 ContactJon Brumbaugh
888-345-0374
Manufacturer Reason
for Recall		Potential for device to not deliver full amount of energy
FDA Determined
Cause 2		Other
ActionOn 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 Commerce363
DistributionDevices were distributed to physicians and medical centers throughout the U.S. The firm does not distribute internationally.
Total Product Life CycleTPLC 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.
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