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U.S. Department of Health and Human Services

Class 2 Device Recall Optima Mobile Xray System

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  Class 2 Device Recall Optima Mobile Xray System see related information
Date Initiated by Firm November 07, 2013
Date Posted January 11, 2014
Recall Status1 Terminated 3 on May 06, 2014
Recall Number Z-0725-2014
Recall Event ID 67136
510(K)Number K103476  
Product Classification System, x-ray, mobile - Product Code IZL
Product GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems. Model numbers 5555000-5, 5555000-6, and 5421698.
Code Information Serial Numbers: 00000002796EN1, 00000002797EN9, 00000002798EN7, 00000002799EN5, 00000002800EN1, 00000002801EN9, 00000102726WK9, 00000102789WK3, 00000102937WK7, 00000130778WK3, 00000UA45526-8, 00001027058WK5, 00001027061WK9, 00001027146WK8, 00001027149WK2, 00001027150WK0, 00001027151WK8, 00001027153WK4, 00001027154WK2, 00001027167WK4, 00001027168WK2, 00001027169WK0, 00001027175WK7, 00001027193WK0, 00001027194WK8, 00001027195WK5, 00001027199WK7, 00001027200WK3, 00001027203WK7, 00001027204WK5, 00001027207WK8, 00001027214WK4, 00001027256WK5, 00001027259WK9, 00001027260WK7, 00001027262WK3, 00001027264WK9, 00001027265WK6, 00001027267WK2, 00001027268WK0, 00001027269WK8, 00001027276WK3, 00001027277WK1, 00001027278WK9, 00001027280WK5, 00001027293WK8, 00001027294WK6, 00001027295WK3, 00001027297WK9, 00001027298WK7, 00001027299WK5, 00001027300WK1, 00001027301WK9, 00001027302WK7, 00001027303WK5, 00001027314WK2, 00001027318WK3, 00001027322WK5, 00001027323WK3, 00001027324WK1, 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Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact Call Center
800-437-1171
Manufacturer Reason
for Recall		 There exists a software issue associated with patient selection from the worklist on the Optima XR200 with Digital Upgrade, and Optima XR220amx Mobile X-ray Systems. Intermittently when a large number of patient exams are retrieved from the HIS/RIS system, the exams when displayed on the mobile x-ray system are not properly displayed. If the user continues to attempt to select one of the exams w
FDA Determined
Cause 2		 Software design
Action GE sent an Urgent Medical Device Correction letter, dated 11/7/2013 to consignees. The letter described the issue, identified devices affected and stated that users should pay close attention to the patient exam/entry selected from the worklist prior to selecting the Start Exam button to ensure that the system did not update and select an incorrect exam. The user may also confirm during the exam that the appropriate patient information was selected via the display on the upper left portion. GE will fix the units with a software fix at no cost.
Quantity in Commerce 1027
Distribution Worldwide Distribution-USA (nationwide) including Washington D.C., and Guam and the countries of ALBANIA, AUSTRALIA, BAHRAIN, BELGIUM, BRAZIL, CANADA, CHILE, CHINA , COLOMBIA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HUNGARY, INDIA, IRAQ, IRELAND, ITALY, JAPAN, JORDAN, KOREA, REPUBLIC OF, KUWAIT, MALAYSIA, MEXICO, NEW ZEALAND, NIGERIA, NORWAY, POLAND, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, THAILAND, TRINIDAD AND TOBAGO, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.
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
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