FDAFDA · Food and drugs·Recall number Z-1942-2013
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.
Published August 21, 2013 · Recall initiated: August 7, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- GE Healthcare, LLC
- Distributor
- 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.
- Lot
- 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 00001027292WK0 00001028037WK8 00001027352WK2 00001027382WK9 00001027345WK6 00001027879WK4 00001028044WK4 00001028075WK8 00001027768WK9 00001027152WK6 00001028025WK3 00001027820WK8 00001027262WK3 00001027774WK7 00001028080WK8 00001028078WK2 00001027501WK4 00001027505WK5 00001028294WK5 00001027361WK3 00001028041WK0 00001028065WK9 00001027322WK5 00001027387WK8 00001027362WK1 00001027344WK9 00001027359WK7 00001028401WK6 00001028491WK7 00001027371WK2 00001028279WK6 00001028276WK2 00001028231WK7 00001028267WK1 00001028076WK6 00001027824WK0 00001027450WK4 00001027992WK5 00001027895WK0 00001027775WK4 00001027421WK5 00001027894WK3 00001027503WK0 00001027693WK9 00001028235WK8 00001028040WK2 00001028039WK4 00001028337WK2 00001027169WK0 00001027207WK8 00001027376WK1 00001027214WK4 00001027356WK3 00001027383WK7 00001027490WK0 00001027773WK9 00001027369WK6 00001027380WK3 00001027583WK2 00001028292WK9 00001028341WK4 00001028291WK1 00001028213WK5 00001027317WK5 00001028284WK6 00001028278WK8 00001027296WK1 00001028115WK2 00001028021WK2 00001027466WK0 00001027996WK6 00001027994WK1 00001028035WK2 00001028034WK5 00001028365WK3 00001028094WK9 00001027390WK2 00001027167WK4 00001027294WK6 00001027822WK4 00001027544WK4 00001028092WK3 00001027354WK8 00001027825WK7 00001027271WK4 00001027541WK0 00001027506WK3 00001028465WK1 00001027385WK2 00001027052WK8 00001028273WK9 00001027355WK5 00001027299WK5 00001027892WK7 00001027407WK4 00001027422WK3 00001027406WK6 00001027353WK0 00001029030WK2 00001027350WK6 00001027939WK6 00001028288WK7 00001027416WK5 00001027737WK4 00001027991WK7 00001027279WK7 00001027327WK4 00001027989WK1 00001028033WK7 00001027389WK4 00001027465WK2 00001028210WK1 00001028061WK8 00001027736WK6 00001027272WK2 00001028237WK4 00001028363WK8 00001027303WK5 00001028114WK5 00001027988WK3 00001027987WK5 00001028478WK4 00001027748WK1 00001028077WK4 00001028050WK1 00001027278WK9 00001028064WK2 00001027582WK4 00001027891WK9 00001028003WK0 00001027765WK5 00001027326WK6 00001027153WK4 00001027444WK7 00001027934WK7 00001028113WK7 00001027203WK7 00001027295WK3 00001027451WK2 00001028482WK6 00001027779WK6 00001027700WK2 00001027386WK0 00001027438WK9 00001028227WK5 00001027887WK7 00001027888WK5 00001027280WK5 00001028398WK4 00001028339WK8 00001028352WK1 00001028354WK7 00001028207WK7 00001028282WK0 00001028332WK3 00001028281WK2 00001027318WK3 00001027301WK9 00001028038WK6 00001027384WK5 00001027417WK3 00001027699WK6 00001027553WK5 00001027508WK9 00001027766WK3 00001028042WK8 00001027540WK2 00001027584WK0 00001028053WK5 00001027995WK8 00001027489WK2 00001027168WK2 00001027298WK7 00001027360WK5 00001027370WK4 00001028238WK2 00001028490WK9 00001027896WK8 00001028036WK0 00001028043WK6 00001027267WK2 00001027878WK6 00001027464WK5 00001027762WK2 00001028283WK
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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