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 |
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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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