Class 2 Device Recall OEC 9800, OEC 9900 Elite

• Date Initiated by Firm: May 08, 2020
• Date Posted: August 27, 2020
• Recall Status: Open, Classified
• Recall Number: Z-2872-2020
• Recall Event ID: 86201
• 510(K)Number: K111551 K120613 K122234 K132027
• Product Classification: C-arm fluoroscopic x-ray system - Product Code RCC
• Product: The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical-care and emergency room procedures. The GE OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures, and is also intended for cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, critical care and emergency room procedures.
• Code Information: OEC 9800, OEC 9900 Elite
• Recalling Firm/ Manufacturer: Ge Healthcare; 384 Wright Brothers Dr; Salt Lake City UT 84116-2862
• For Additional Information Contact: Troy Perry; 801-536-4890
• Manufacturer Reason for Recall: GEHC Surgery became aware that some users of the 9800 and 9900 fluoroscopic mobile C-Arms (referred to as the system here on) within the United States had requested that a Field Service Engineer (FSE) change the dose value on the live update screen from AKR / CAK to DAP. All systems sold to customers in the US that leave GEHC Surgery (the place of manufacture) are configured to display AKR / CAK when they leave the factory. An FSE changing the dose display, per the customer request, to display DAP instead does not comply to 21CFR 1020.32(k), which requires fluoroscopic equipment manufactured on or after June 10, 2006 to display continuous updates of AKR and CAK values.
• FDA Determined Cause: Radiation Control for Health and Safety Act
• Quantity in Commerce: 221
• Distribution: Nationwide
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

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