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Class 2 Device Recall OEC 8800 |
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Date Initiated by Firm |
March 01, 2007 |
Date Posted |
September 28, 2007 |
Recall Status1 |
Terminated 3 on May 01, 2012 |
Recall Number |
Z-0678-2007 |
Recall Event ID |
37498 |
510(K)Number |
K003837
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Product Classification |
Image-intensified fluoroscopic x-ray system - Product Code JAA
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Product |
OEC 8800 image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT. |
Code Information |
Serial Numbers: FIB-0020, FIB-0025, FIB-0038, FIB-0050, FIB-0065, 2799PU5, 2832PU4, 3380PU3, 3589PU9, 4037PU8, 4816PU5, 4842PU1, 4860PU3, 5190PU4, 5204PU3, 5210PU0, 5270PU6. |
Recalling Firm/ Manufacturer |
GE OEC Medical Systems, Inc 384 Wright Brothers Dr Salt Lake City UT 84116-2862
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For Additional Information Contact |
Karen Tolson 847-501-1884
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Manufacturer Reason for Recall |
During routine service, primary and/or secondary collimators may not have been properly reinstalled.
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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 |
17 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 and Original Applicant = GE OEC MEDICAL SYSTEMS
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