GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems. Model numbers 5555000-5, 5555000-6, and 5421698.
Publicado el 22 de enero de 2014 · Inicio del retiro: 7 de noviembre de 2013
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- GE Healthcare, LLC
- Distribuidor
- 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.
- Lote
- 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, 00001027325WK8, 00001027326WK6, 00001027344WK9, 00001027346WK4, 00001027347WK2, 00001027349WK8, 00001027350WK6, 00001027351WK4, 00001027352WK2, 00001027353WK0, 00001027354WK8, 00001027356WK3, 00001027359WK7, 00001027362WK1, 00001027363WK9, 00001027364WK7, 00001027369WK6, 00001027371WK2, 00001027372WK0, 00001027373WK8, 00001027374WK6, 00001027376WK1, 00001027377WK9, 00001027380WK3, 00001027382WK9, 00001027383WK7, 00001027384WK5, 00001027386WK0, 00001027387WK8, 00001027388WK6, 00001027389WK4, 00001027390WK2, 00001027406WK6, 00001027407WK4, 00001027416WK5, 00001027417WK3, 00001027418WK1, 00001027421WK5, 00001027422WK3, 00001027423WK1, 00001027438WK9, 00001027445WK4, 00001027450WK4, 00001027451WK2, 00001027452WK0, 00001027464WK5, 00001027465WK2, 00001027466WK0, 00001027487WK6, 00001027488WK4, 00001027489WK2, 00001027490WK0, 00001027506WK3, 00001027507WK1, 00001027508WK9, 00001027539WK4, 00001027540WK2, 00001027541WK0, 00001027542WK8, 00001027543WK6, 00001027544WK4, 00001027551WK9, 00001027552WK7, 00001027553WK5, 00001027582WK4, 00001027583WK2, 00001027699WK6, 00001027700WK2, 00001027736WK6, 00001027737WK4, 00001027749WK9, 00001027762WK2, 00001027764WK8, 00001027765WK5, 00001027766WK3, 00001027768WK9, 00001027769WK7, 00001027772WK1, 00001027773WK9, 00001027774WK7, 00001027775WK4, 00001027778WK8, 00001027779WK6, 00001027781WK2, 00001027814WK1, 00001027819WK0, 00001027820WK8, 00001027821WK6, 00001027823WK2, 00001027824WK0, 00001027825WK7, 00001027826WK5, 00001027827WK3, 00001027828WK1, 00001027878WK6, 00001027880WK2, 00001027887WK7, 00001027888WK5, 00001027889WK3, 00001027890WK1, 00001027891WK9, 00001027892WK7, 00001027893WK5, 00001027894WK3, 00001027895WK0, 00001027896WK8, 00001027915WK6, 00001027932WK1, 00001027934WK7, 00001027935WK4, 00001027939WK6, 00001027992WK5, 00001027993WK3, 00001027994WK1, 00001027995WK8, 00001027996WK6, 00001028003WK0, 00001028021WK2, 00001028022WK0, 00001028023WK8, 00001028025WK3, 00001028035WK2, 00001028036WK0, 00001028042WK8, 00001028043WK6, 00001028044WK4, 00001028050WK1, 00001028051WK9, 00001028052WK7, 00001028053WK5, 00001028064WK2, 00001028065WK9, 00001028066WK7, 00001028077WK4, 00001028078WK2, 00001028079WK0, 00001028080WK8, 00001028091WK5, 00001028092WK3, 00001028093WK1, 00001028094WK9, 00001028119WK4, 00001028120WK2, 00001028205WK1, 00001028213WK5, 00001028214WK3, 00001028215WK0, 00001028216WK8, 00001028217WK6, 00001028230WK9, 00001028231WK7, 00001028232WK5, 00001028267WK1, 00001028269WK7, 00001028275WK4, 00001028276WK2, 00001028277WK0, 00001028279WK6, 00001028280WK4, 00001028281WK2, 00001028283WK8, 00001028284WK6, 00001028285WK3, 00001028286WK1, 00001028287WK9, 00001028288WK7, 00001028289WK5, 00001028290WK3, 00001028291WK1, 00001028292WK9, 00001028294WK5, 00001028331WK5, 00001028333WK1, 00001028334WK9, 00001028337WK2, 00001028338WK0, 00001028339WK8, 00001028340WK6, 00001028341WK4, 00001028342WK2, 00001028343WK0, 00001028344WK8, 00001028345WK5, 00001028346WK3, 00001028347WK1, 00001028351WK3, 00001028352WK1, 00001028353WK9, 00001028354WK7,
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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