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Class 2 Device Recall Programmable Stimulator |
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Date Initiated by Firm |
January 13, 2005 |
Date Posted |
April 19, 2005 |
Recall Status1 |
Terminated 3 on March 13, 2012 |
Recall Number |
Z-0713-05 |
Recall Event ID |
30986 |
510(K)Number |
K991293
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Product Classification |
Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only) - Product Code JOQ
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Product |
Bloom DTU-215-B Programmable Stimulator |
Code Information |
All Bloom DTU-215-B Programmable Stimulators. |
Recalling Firm/ Manufacturer |
Fischer Imaging Corporation 12300 Grant St Denver CO 80241-3120
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For Additional Information Contact |
Tom Gibson 303-254-2525
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Manufacturer Reason for Recall |
Possibility that after a loss of power or brown-out, the device may transmit unintended stimulation to patients.
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FDA Determined Cause 2 |
Other |
Action |
Customers were notified by letter on 01/13/05. |
Quantity in Commerce |
712 units |
Distribution |
Nationwide. Foreign distribution: Canada, Australia, Ireland, Italy, Japan, Malaysia, Switzerland, Netherlands, United Kingdom. |
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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510(K) Database |
510(K)s with Product Code = JOQ and Original Applicant = FISCHER MEDICAL TECHNOLOGIES, INC.
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