| Class 2 Device Recall OEC 9800 MD Motorized CArm System |  |
Date Initiated by Firm | March 01, 2007 |
Date Posted | September 28, 2007 |
Recall Status1 |
Terminated 3 on May 01, 2012 |
Recall Number | Z-0681-2007 |
Recall Event ID |
37498 |
510(K)Number | K021049 K022069 K024012 |
Product Classification |
Image-intensified fluoroscopic x-ray system - Product Code JAA
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Product | OEC 9800 MD Motorized C-Arm System, image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT. |
Code Information |
Serial numbers: 82-7001-MH, 82-7004-MH, 82-7006-MH, 82-7009-MH, 82-7024-MH, 82-7034-MH, 82-7077-MH, 82-7086-MH, 82-7096-MH, 82-7098-MH, 82-7105-MH, 82-7110-MH, 82-7139-MH, 82-2061-C, 82-1094-C, 82-0619-M, 89-0483-C, 8S-7031-MH, 8S-7035-MH-RC, 8S-7047-MH, 8S-7075-CMH, 8S-7127-MH, 8S-7145-MH, 8S-7164-CMH, 8S-2791-C, 8S-2518-C, 8S-2519-C, 8S-2046-C, 8S-2054-C, 8S-1911-C, 8S-1772-C, 8S-1632-C, 8S-1490-C, 8S-1449-C, 8S-1224-C-RC, 8S-1212-C, 8S-1069-C, 8S-1065-C, 8S-1013-C, 8S-0849-C, 8S-0793-C, 8S-0790-C, 8S-0754-C, 8S-0744-C, 8S-0721-C, 8S-0717-C, 8S-0708-C, 8S-0678-C, 8S-0615-C, 8S-0559-C, 8S-0521-C, 8S-0510-C-RC, 8S-0421-C, 8S-0413-C, 8S-0405-C, 8S-0348-C-RC, 8S-0300-C, 8S-0192-C, 8S-0143-C, 8S-0144-C, 8S-0148-C, 8S-0140-C, 8S-0141-C, 8S-0093-C, 8S-0055-C, 8S-0011-C, 8S-0014-C, 8S-0016-C, 8S-0005-C, 8S-0006-C-RC. |
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 |
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 | 70 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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