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U.S. Department of Health and Human Services

Class 2 Device Recall Programmable Stimulator

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  Class 2 Device Recall Programmable Stimulator see related information
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  
Product Classification Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only) - Product Code JOQ
Product Bloom DTU-215-B Programmable Stimulator
Code Information All Bloom DTU-215-B Programmable Stimulators.
Recalling Firm/
Fischer Imaging Corporation
12300 Grant St
Denver CO 80241-3120
For Additional Information Contact Tom Gibson
Manufacturer Reason
for Recall
Possibility that after a loss of power or brown-out, the device may transmit unintended stimulation to patients.
FDA Determined
Cause 2
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

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.
510(K) Database 510(K)s with Product Code = JOQ and Original Applicant = FISCHER MEDICAL TECHNOLOGIES, INC.