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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 Device Recall OEC 9800 MD Motorized CArm System see related information
Date Posted September 28, 2007
Recall Status1 Terminated on May 01, 2012
Recall Number Z-0681-2007
Recall Event ID 37498
510(K)Number K024012  K022069  K021049 
Product Classification Image-intensified fluoroscopic x-ray system - 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/
GE OEC Medical Systems, Inc
384 Wright Brothers Dr
Salt Lake City UT 84116-2862
For Additional Information Contact Karen Tolson
Manufacturer Reason
for Recall
During routine service, primary and/or secondary collimators may not have been properly reinstalled.
FDA Determined
Cause 2
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