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U.S. Department of Health and Human Services

Class 2 Device Recall OEC 9800 MD Motorized CArm System

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 Class 2 Recall
OEC 9800 MD Motorized CArm System
see related information
Date Posted September 28, 2007
Recall Status1 Open
Recall Number Z-0681-2007
Recall Event ID 37498
Premarket Notification
510(K) Numbers
K003837  K021049  K022069  K024012  K041932 
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
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, Utah 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
PRODUCTION CONTROLS: Process Control
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

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JAA and Original Applicant = GE OEC MEDICAL SYSTEMS
510(K)s with Product Code = JAA and Original Applicant = GE OEC MEDICAL SYSTEMS, INC.
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