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U.S. Department of Health and Human Services

Class 2 Device Recall Electrophysiology Imaging System

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  Class 2 Device Recall Electrophysiology Imaging System see related information
Date Initiated by Firm April 28, 2005
Date Posted September 09, 2005
Recall Status1 Terminated 3 on March 13, 2012
Recall Number Z-1527-05
Recall Event ID 31930
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
Product Electrophysiology Imaging System
Code Information Model EPX-60, Product Number 105375G
Recalling Firm/
Manufacturer
Fischer Imaging Corporation
12300 Grant St
Denver CO 80241-3120
For Additional Information Contact
303-254-2525
Manufacturer Reason
for Recall
Belt driving the Image Intensifier may break, causing the Intensifier to slip down, possibly causing injury to patient.
FDA Determined
Cause 2
Other
Action Consignees were notified by certified letter on 04/27/2005.
Quantity in Commerce 5 units
Distribution Nationwide, including VA facilities in GA and TX. Foreign distribution to Australia, Mexico and Poland. No military distribution.
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.
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