Class 2 Device Recall OEC 9800

• Date Initiated by Firm: March 01, 2007
• Date Posted: September 28, 2007
• Recall Status: Terminated on May 01, 2012
• Recall Number: Z-0677-2007
• Recall Event ID: 37498
• 510(K)Number: K021049 K022069 K024012
• Product Classification: Image-intensified fluoroscopic x-ray system - Product Code JAA
• Product: OEC 9800 image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT.
• Code Information: Serial Numbers: 429 units within the range 8S-0007 thru 8S-7163, 455 units within the range 89-0014 thru 89-3520, 659 units within the range 82-0010 thru 82-7138.
• Recalling Firm/ Manufacturer: GE OEC Medical Systems, Inc; 384 Wright Brothers Dr; Salt Lake City UT 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: 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: 1857 units
• Distribution: Nationwide and Germany.
• Total Product Life Cycle: TPLC Device Report

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.

• 510(K) Database: 510(K)s with Product Code = JAA