Class 2 Device Recall Programmable Stimulator

• Date Initiated by Firm: January 13, 2005
• Date Posted: April 19, 2005
• Recall Status: Terminated 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/ Manufacturer: Fischer Imaging Corporation; 12300 Grant St; Denver CO 80241-3120
• For Additional Information Contact: Tom Gibson; 303-254-2525
• 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: 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

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