Class 2 Device Recall Precision 500D R&F System

• Date Initiated by Firm: June 12, 2015
• Date Posted: July 02, 2015
• Recall Status: Terminated on December 21, 2015
• Recall Number: Z-1966-2015
• Recall Event ID: 71572
• 510(K)Number: K081091 K973039
• Product Classification: System, x-ray, fluoroscopic, image-intensified - Product Code JAA
• Product: GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Systems.; ; A universal diagnostic imaging system for radiographic and fluoroscopic examinations. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. ; ; Legacy and Legacy D Table is intended for use in a diagnostic X-ray system to support patient during general purpose radiological procedures in the horizontal, vertical and Trendelenburg positions.
• Code Information: Mfg Lot or Serial # Model, Catalogue or Code # 00000959002WK7 2258627 00000966338WK6 2258627 00000966611WK6 2258627 00000956387WK5 2258627 00000968741WK9 2258627 00000961510WK5 2258627 00000972529WK2 2258627 00000962527WK8 2258627 00000963526WK9 2258627 00000955594WK7 2258627 00000956587WK0 2258627 00000959354WK2 2258627 00000964963WK3 2258627 00000955822WK2 2258627 00000969028WK0 2258627 00000970010WK5 2258627 00000977743WK4 2258627 00000977741WK8 2258627 00000961823WK2 2258627 00000966949WK0 2258627 00000974520WK9 2258627 00000969300WK3 2258627 00000980632WK4 2258627 00000968416WK8 2258627 00000954452WK9 2258627 00000976569WK4 2258627 00000966357WK6 2258627 00000965746WK1 2258627 00000973833WK7 2258627 00000968411WK9 2258627 00000981014WK4 2258627 00000978814WK2 2258627 00000983374WK0 2258627 00000969352WK4 2258627 00000956745WK4 2258627 00000959683WK4 2258627 00000960138WK6 2258627 00000978807WK6 2258627 00000966622WK3 2258627 00000972384WK2 2258627 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• Recalling Firm/ Manufacturer: GE Healthcare; 3000 N Grandview Blvd; Waukesha WI 53188-1615
• For Additional Information Contact: GE Healthcare Service; 800-437-1171
• Manufacturer Reason for Recall: The SFD/IDD safety mechanism may not engage properly at the lower range of SFD/IDD travel. This mechanism is installed to hold and prevent the SFD/IDD from falling due to a counterweight cable failure. The lower range of travel is 1.1 in (28mm) from the lowest point of normal SFD/IDD vertical compression. A fall of the SFD/IDD could result in an injury to a patient or operator.
• FDA Determined Cause: Nonconforming Material/Component
• Action: GE Healthcare sent an "Urgent Medical Device Correction" letter GEHC Ref#10902 dated June 12, 2015 to Hospital Administrators/Risk Managers, Managers of Radiology/Cardiology and Radiologists/Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
• Quantity in Commerce: 4,053 (3,804 US; 249 OUS)
• Distribution: Worldwide Distribution - US Nationwide including PR, GU and DC and the countries of: Afghanistan, Argentina, Australia, Austria, Belgium, Bermuda, Canada, Cayman Islands, Chile, Colombia, Czech Republic, Dominican Republic, Ecuador, Egypt, France, Germany, Ghana, Guatemala, Honduras, Indonesia, Ireland, Israel, Italy, Jamaica, Jordan, Korea (Republic of), Kuwait, Libyan Arab Jamahiriya, Malaysia, Malta, Mexico, New Zealand, Panama, Romania, Russia, Saudi Arabia, Spain, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Vietnam, and Yemen.
• 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 and Original Applicant = GE HEALTHCARE; 510(K)s with Product Code = JAA and Original Applicant = GE MEDICAL SYSTEMS