Class 2 Device Recall GE Healthcare OEC 9900 Elite

• Date Initiated by Firm: December 27, 2016
• Date Posted: January 20, 2017
• Recall Status: Terminated on July 12, 2018
• Recall Number: Z-1060-2017
• Recall Event ID: 76074
• 510(K)Number: K120613 K122234
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: OEC 9900 Elite. MDL Numbers: D148942, D155043
• Code Information: Manufactured from Oct 2005 to present
• Recalling Firm/ Manufacturer: GE OEC Medical Systems, Inc; 384 N Wright Brothers Dr; Salt Lake City UT 84116-2862
• For Additional Information Contact: Deena Pease; 801-536-4952
• Manufacturer Reason for Recall: GE Healthcare Surgery announces a voluntary field action for the OEC 9800 and OEC 9900 Elite due to additional supplementation to the user documentation to include areas for enhanced planned maintenance and component replacement frequencies.
• FDA Determined Cause: Packaging change control
• Action: The customer communication is expected to begin distribution in January 2017. Consignees will be notified of the availability of the Operator Manual supplement via a letter. No product is being returned.
• Quantity in Commerce: 26,256 total
• Distribution: Worldwide including govt/VA/military and foreign consignees.
• 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 = OWB