| Class 2 Device Recall OEC 9800 | |
Date Initiated by Firm | February 09, 2007 |
Date Posted | March 22, 2007 |
Recall Status1 |
Terminated 3 on June 26, 2007 |
Recall Number | Z-0556-2007 |
Recall Event ID |
37322 |
510(K)Number | K021049 K022069 K024012 |
Product Classification |
Image-intensified fluoroscopic x-ray system. - Product Code JAA
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Product | OEC 9800 Fluoroscopic X-ray System, Model Number A349855, GE Healthcare, Surgery. |
Code Information |
Model Number A349855. Serial numbers: 82-7092-MH, 89-0247-RC, 89-0599, 89-0972, 89-1001, 89-1685, 89-2383, 89-2877, 89-2907, 89-2987, 89-3330. |
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 | Ms. Karen Tolson 847-501-1884 |
Manufacturer Reason for Recall | During routine service, a cover may have been installed without the required proper lead shielding. |
FDA Determined Cause 2 | Other |
Action | Consignees were notified by telephone on 02/09/2007 and told to discontinue use of the units until they could be inspected by GE personnel. GE personnel visited all 8 sites on 02/12/2007. |
Quantity in Commerce | 11 units of all models |
Distribution | Nationwide to AL, AZ, IA, OH, TX, VA, and WV. |
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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