Date Initiated by Firm | August 16, 2006 |
Date Posted | September 30, 2006 |
Recall Status1 |
Terminated 3 on July 27, 2011 |
Recall Number | Z-1302-06 |
Recall Event ID |
36099 |
510(K)Number | K024012 |
Product Classification |
X-ray - Product Code JAA
|
Product | GE OEC 9800 Fluoro C-Arm X-ray System, GE OEC Medical Systems Inc. |
Code Information |
All units |
Recalling Firm/ Manufacturer |
GE OEC Medical Systems, Inc 384 Wright Brothers Dr Salt Lake City UT 84116-2862
|
For Additional Information Contact | 801-328-9300 |
Manufacturer Reason for Recall | X-ray systems could provide output which exceeds the 20 R/minute limit. |
FDA Determined Cause 2 | Other |
Action | Consignees were notified by certified letter on 08/14-15/2006. |
Quantity in Commerce | 8,266 units (US), 2,664 units (foreign) |
Distribution | Worldwide |
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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