Tachos DR - Implantable Cardioverter Defibrillator
Hazard
Potential for device to not deliver full amount of energy
What You Should Do
Remedy
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.
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Products
Tachos DR - Implantable Cardioverter Defibrillator
- Brand
- Biotronik Inc
- UPC
- 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
Units Affected
363