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U.S. Department of Health and Human Services

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

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 Class 2 Recall
Optima XR220amx, Optima XR200amx, and Brivo XR285amx
see related information
Date Posted August 09, 2013
Recall Status1 Terminated on February 04, 2014
Recall Number Z-1942-2013
Recall Event ID 64992
Premarket Notification
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.
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Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
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 2
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IZL and Original Applicant = GE MEDICAL SYSTEMS, LLC
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