Class 2 Device Recall Optima XR220amx, Optima XR200amx, and Brivo XR285amx

• Date Initiated by Firm: August 07, 2012
• Date Posted: August 09, 2013
• Recall Status: Terminated on February 04, 2014
• Recall Number: Z-1942-2013
• Recall Event ID: 64992
• 510(K)Number: K103476
• Product Classification: System, x-ray, mobile - Product Code IZL
• Product: GE Healthcare, Optima XR220amx, Optima XR200amx, and Brivo XR285amx.; ; The series are indicated for use on adult and pediatric patients for general-purpose diagnostic radiographic examinations and procedures. The systems are indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body pants with the patient sitting, standing, or lying in the prone or supine position. These devices are not intended for mammographic applications.
• Code Information: Serial # 1028082 00000102856WK4 00001027044WK5 00001027046WK0 00001027160WK9 00001027162WK5 00001027164WK1 00001027174WK0 00001027446WK2 00001027449WK6 00001027526WK1 00001027570WK9 00001027739WK0 00001027881WK0 00001027897WK6 00001027900WK8 00001027901WK6 00001027902WK4 00001027903WK2 00001027904WK0 00001027942WK0 00001028045WK1 00001028046WK9 00001028047WK7 00001028048WK5 00001028063WK4 00001028082WK4 00001028219WK2 00001028300WK0 00001028301WK8 00001028304WK2 00001028454WK5 00001028460WK2 00001028461WK0 00001028564WK1 00001028590WK6 00001028591WK4 00001028592WK2 00001028593WK0 00001028594WK8 00001028616WK9 00001028648WK2 00001028649WK0 00001028650WK8 00001028651WK6 00001028653WK2 00001028655WK7 00001028656WK5 00001028657WK3 00001028861WK1 00001028867WK8 00001028931WK2 00001028102WK0 00000102866WK4 00001028918WK9 00001027502WK2 00001027935WK4 00001028206WK9 00001028079WK0 00001028230WK9 00001028277WK0 00001028913WK0 00001027984WK2 00001027349WK8 00001027217WK7 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• Recalling Firm/ Manufacturer: GE Healthcare, LLC; 3000 N Grandview Blvd; Waukesha WI 53188-1615
• For Additional Information Contact: 262-513-4122
• Manufacturer Reason for Recall: GE Healthcare conducted a recall on various mobile x-ray units (Optima XR220amx, Optima XR200amx, and Brivo XR285amx systems) because of an Erratic Drive Performance.
• FDA Determined Cause: Software design
• Action: GE Healthcare recall strategy was to update all of the affected Optima XR220amx, Optima XR200amx, and Brivo XR285amx systems that were distributed. At this time ( 2/14/2013), deployment of this recall is considered complete. Should you have any questions or require additional information, please contact Regulatory Affairs Leader by telephone at 262-548-2198 or email paulcorrigan@ge.com
• Quantity in Commerce: 458 (306 US; 152 OUS)
• Distribution: Worldwide distribution: USA (nationwide) including states of: AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, GUAM, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MS, MO, NV, NH, NH, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY; and countries of: Albania, Australia, Bahrain, Belgium, Canada, Chile, Czech Republic, Dominican Republic, France, Germany, Great Britain, Honduras, Hungary, Ireland, Israel, Italy, Japan, Korea, Kuwait, Netherlands, Nigeria, Norway, Romania, Saudi Arabia, Spain, United Arab Emirates and Venezuela.
• 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 = IZL and Original Applicant = GE MEDICAL SYSTEMS, LLC