Date Initiated by Firm | March 01, 2007 |
Date Posted | September 28, 2007 |
Recall Status1 |
Terminated 3 on May 01, 2012 |
Recall Number | Z-0679-2007 |
Recall Event ID |
37498 |
510(K)Number | K041932 |
Product Classification |
Image-intensified fluoroscopic x-ray system - Product Code JAA
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Product | OEC 9900 Elite MD Motorized C-Arm System, image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT. |
Code Information |
Serial Numbers: E2-7075-MH, ES-0029-CH, ES-0046-CH, ES-0066-CH, ES-0131-H. |
Recalling Firm/ Manufacturer |
GE OEC Medical Systems, Inc 384 Wright Brothers Dr Salt Lake City UT 84116-2862
|
For Additional Information Contact | Karen Tolson 847-501-1884 |
Manufacturer Reason for Recall | During routine service, primary and/or secondary collimators may not have been properly reinstalled. |
FDA Determined Cause 2 | Other |
Action | Customers were notified by letter on 03/01/2007. They were told to continue using the machines and that an inspection would be scheduled immediately to verify that collimators had been correctly installed. |
Quantity in Commerce | 5 units |
Distribution | Nationwide and Germany. |
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 = JAA
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