Events

Rappel de Device Recall Optima Mobile Xray System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par GE Healthcare, LLC.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    67136
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0725-2014
  • Date de mise en oeuvre de l'événement
    2013-11-07
  • Date de publication de l'événement
    2014-01-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-05-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124760
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    System, x-ray, mobile - Product Code IZL
  • Cause
    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.
  • 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.

Device

Device Recall Optima Mobile Xray System
  • Modèle / numéro de série
    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, 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00001028353WK9, 00001028354WK7, 00001028363WK8, 00001028365WK3, 00001028369WK5, 00001028370WK3, 00001028396WK8, 00001028397WK6, 00001028398WK4, 00001028399WK2, 00001028464WK4, 00001028465WK1, 00001028467WK7, 00001028468WK5, 00001028469WK3, 00001028470WK1, 00001028471WK9, 00001028472WK7, 00001028476WK8, 00001028477WK6, 00001028478WK4, 00001028501WK3, 00001028502WK1, 00001028503WK9, 00001028505WK4, 00001028506WK2, 00001028517WK9, 00001028518WK7, 00001028519WK5, 00001028520WK3, 00001028522WK9, 00001028523WK7, 00001028524WK5, 00001028536WK9, 00001028537WK7, 00001028538WK5, 00001028539WK3, 00001028559WK1, 00001028560WK9, 00001028561WK7, 00001028562WK5, 00001028563WK3, 00001028574WK0, 00001028575WK7, 00001028576WK5, 00001028605WK2, 00001028617WK7, 00001028621WK9, 00001028680WK5, 00001028681WK3, 00001028682WK1, 00001028683WK9, 00001028685WK4, 00001028686WK2, 00001028687WK0, 00001028688WK8, 00001028689WK6, 00001028690WK4, 00001028691WK2, 00001028692WK0, 00001028693WK8, 00001028694WK6, 00001028695WK3, 00001028716WK7, 00001028717WK5, 00001028718WK3, 00001028719WK1, 00001028799WK3, 00001028800WK9, 00001028801WK7, 00001028802WK5, 00001028803WK3, 00001028850WK4, 00001028851WK2, 00001028852WK0, 00001028853WK8, 00001028854WK6, 00001028855WK3, 00001028856WK1, 00001028857WK9, 00001028858WK7, 00001028859WK5, 00001028889WK2, 00001028890WK0, 00001028891WK8, 00001028895WK9, 00001028896WK7, 00001028897WK5, 00001028898WK3, 00001028899WK1, 00001028900WK7, 00001028901WK5, 00001028902WK3, 00001028916WK3, 00001028917WK1, 00001028977WK5, 00001028979WK1, 00001028980WK9, 00001028982WK5, 00001028983WK3, 00001028984WK1, 00001028985WK8, 00001028986WK6, 00001028989WK0, 00001028990WK8, 00001028991WK6, 00001028992WK4, 00001028993WK2, 00001028994WK0, 00001028995WK7, 00001028996WK5, 00001028997WK3, 00001028998WK1, 00001029036WK9, 00001029037WK7, 00001029038WK5, 00001029039WK3, 00001029040WK1, 00001029041WK9, 00001029042WK7, 00001029043WK5, 00001029044WK3, 00001029046WK8, 00001029048WK4, 00001029049WK2, 00001029050WK0, 00001029051WK8, 00001029052WK6, 00001029053WK4, 00001029054WK2, 00001029055WK9, 00001029062WK5, 00001029066WK6, 00001029067WK4, 00001029068WK2, 00001029069WK0, 00001029070WK8, 00001029159WK9, 00001029160WK7, 00001029161WK5, 00001029162WK3, 00001029163WK1, 00001029212WK6, 00001029220WK9, 00001029366WK0, 00001029373WK6, 00001029374WK4, 00001029375WK1, 00001029376WK9, 00001029378WK5, 00001029442WK9, 00001029443WK7, 00001029444WK5, 00001029446WK0, 00001029460WK1, 00001029461WK9, 00001029462WK7, 00001029464WK3, 00001029465WK0, 00001029472WK6, 00001029473WK4, 00001029475WK9, 00001029476WK7, 00001029521WK0, 00001029523WK6, 00001029539WK2, 00001029540WK0, 00001029541WK8, 00001029542WK6, 00001029543WK4, 00001029544WK2, 00001029545WK9, 00001029546WK7, 00001029566WK5, 00001029567WK3, 00001029568WK1, 00001029569WK9, 00001029570WK7, 00001029571WK5, 00001029572WK3, 00001029573WK1, 00001029574WK9, 00001029575WK6, 00001029592WK1, 00001029593WK9, 00001029594WK7, 00001029595WK4, 00001029597WK0, 00001029598WK8, 00001029614WK3, 00001029615WK0, 00001029616WK8, 00001029620WK0, 00001029621WK8, 00001029622WK6, 00001029625WK9, 00001029626WK7, 00001029628WK3, 00001029630WK9, 00001029631WK7, 00001029632WK5, 00001029635WK8, 00001029636WK6, 00001029639WK0, 00001029640WK8, 00001029641WK6, 00001029642WK4, 00001029643WK2, 00001029649WK9, 00001029650WK7, 00001029651WK5, 00001029652WK3, 00001029653WK1, 00001029654WK9, 00001029655WK6, 00001029656WK4, 00001029657WK2, 00001029658WK0, 00001029674WK7, 00001029675WK4, 00001029676WK2, 00001029677WK0, 00001029678WK8, 00001029679WK6, 00001029681WK2, 00001029683WK8, 00001029684WK6, 00001029685WK3, 00001029693WK7, 00001029694WK5, 00001029695WK2, 00001029696WK0, 00001029697WK8, 00001029698WK6, 00001029699WK4, 00001029700WK0, 00001029701WK8, 00001029702WK6, 00001029724WK0, 00001029725WK7, 00001029726WK5, 00001029727WK3, 00001029728WK1, 00001029729WK9, 00001029733WK1, 00001029734WK9, 00001029735WK6, 00001029736WK4, 00001029737WK2, 00001029738WK0, 00001029739WK8, 00001029740WK6, 00001029741WK4, 00001029742WK2, 00001029743WK0, 00001029744WK8, 00001029745WK5, 00001029746WK3, 00001029747WK1, 00001029755WK4, 00001029756WK2, 00001029758WK8, 00001029759WK6, 00001029762WK0, 00001029763WK8, 00001029764WK6, 00001029766WK1, 00001029767WK9, 00001029768WK7, 00001029769WK5, 00001029770WK3, 00001029786WK9, 00001029787WK7, 00001029796WK8, 00001029797WK6, 00001029804WK0, 00001029813WK1, 00001029814WK9, 00001029820WK6, 00001029821WK4, 00001029825WK5, 00001029826WK3, 00001029827WK1, 00001029828WK9, 00001029861WK0, 00001029862WK8, 00001029863WK6, 00001029864WK4, 00001029865WK1, 00001029868WK5, 00001029869WK3, 00001029870WK1, 00001029885WK9, 00001029886WK7, 00001029887WK5, 00001029888WK3, 00001029889WK1, 00001029890WK9, 00001029900WK6, 00001029901WK4, 00001029902WK2, 00001029903WK0, 00001029931WK1, 00001029932WK9, 00001029933WK7, 00001029934WK5, 00001029935WK2, 00001029941WK0, 00001029948WK5, 00001029949WK3, 00001029950WK1, 00001029951WK9, 00001029952WK7, 00001029953WK5, 00001029954WK3, 00001029955WK0, 00001029956WK8, 00001029959WK2, 00001029960WK0, 00001029961WK8, 00001029962WK6, 00001029963WK4, 00001029969WK1, 00001029970WK9, 00001029973WK3, 00001029974WK1, 00001030002WK8, 00001030003WK6, 00001030004WK4, 00001030008WK5, 00001030009WK3, 00001030010WK1, 00001030011WK9, 00001030012WK7, 00001030025WK9, 00001030026WK7, 00001030027WK5, 00001030028WK3, 00001030029WK1, 00001030031WK7, 00001030032WK5, 00001030033WK3, 00001030035WK8, 00001030045WK7, 00001030046WK5, 00001030049WK9, 00001030050WK7, 00001030052WK3, 00001030054WK9, 00001030057WK2, 00001030065WK5, 00001030075WK4, 00001030082WK0, 00001030206WK5, 00001030210WK7, 00001030211WK5, 00001030212WK3, 00001030216WK4, 00001030217WK2, 00001030218WK0, 00001030219WK8, 00001030235WK4, 00001030236WK2, 00001030239WK6, 00001030240WK4, 00001030241WK2, 00001030242WK0, 00001030243WK8, 00001030269WK3, 00001030270WK1, 00001030271WK9, 00001030272WK7, 00001030273WK5, 00001030284WK2, 00001030285WK9, 00001030286WK7, 00001030287WK5, 00001030288WK3, 00001030289WK1, 00001030290WK9, 00001030291WK7, 00001030292WK5, 00001030293WK3, 00001030366WK7, 00001030367WK5, 00001030368WK3, 00001030369WK1, 00001030371WK7, 00001030406WK1, 00001030407WK9, 00001030408WK7, 00001030432WK7, 00001030433WK5, 00001030437WK6, 00001030438WK4, 00001030510WK0, 00001030511WK8, 00001030512WK6, 00001030513WK4, 00001030514WK2, 00001030531WK6, 00001030532WK4, 00001030533WK2, 00001030534WK0, 00001030535WK7, 00001030536WK5, 00001030537WK3, 00001030538WK1, 00001030539WK9, 00001030540WK7, 00001030557WK1, 00001030558WK9, 00001030559WK7, 00001030560WK5, 00001030561WK3, 00001030562WK1, 00001030585WK2, 00001030586WK0, 00001030587WK8, 00001030588WK6, 00001030589WK4, 00001030590WK2, 00001030591WK0, 00001030592WK8, 00001030593WK6, 00001030594WK4, 00001030595WK1, 00001030596WK9, 00001030597WK7, 00001030598WK5, 00001030602WK5, 00001030603WK3, 00001030604WK1, 00001030605WK8, 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00001030814WK6, 00001030815WK3, 00001030816WK1, 00001030839WK3, 00001030840WK1, 00001030841WK9, 00001030842WK7, 00001030843WK5, 00001030844WK3, 00001030845WK0, 00001030846WK8, 00001030847WK6, 00001030849WK2, 00001030850WK0, 00001030854WK2, 00001030856WK7, 00001030899WK7, 00001030900WK3, 00001030901WK1, 00001030903WK7, 00001030904WK5, 00001030905WK2, 00001030907WK8, 00001030908WK6, 00001030909WK4, 00001030915WK1, 00001030916WK9, 00001030917WK7, 00001030918WK5, 00001030919WK3, 00001030920WK1, 00001030921WK9, 00001030922WK7, 00001030925WK0, 00001030926WK8, 00001030928WK4, 00001030929WK2, 00001030930WK0, 00001030950WK8, 00001030951WK6, 00001030952WK4, 00001030953WK2, 00001030954WK0, 00001030955WK7, 00001030956WK5, 00001030957WK3, 00001030958WK1, 00001030959WK9, 00001030960WK7, 00001030962WK3, 00001030963WK1, 00001030964WK9, 00001030993WK8, 00001030994WK6, 00001030995WK3, 00001031006WK8, 00001031007WK6, 00001031008WK4, 00001031009WK2, 00001031010WK0, 00001031011WK8, 00001031012WK6, 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00001031461WK5, 00001031462WK3, 00001031464WK9, 00001031465WK6, 00001031466WK4, 00001031467WK2, 00001031468WK0, 00001031479WK7, 00001031480WK5, 00001031481WK3, 00001031483WK9, 00001031484WK7, 00001031490WK4, 00001031491WK2, 00001031492WK0, 00001031493WK8, 00001031495WK3, 00001031496WK1, 00001031506WK7, 00001031507WK5, 00001031508WK3, 00001031510WK9, 00001031511WK7, 00001031512WK5, 00001031515WK8, 00001031516WK6, 00001031517WK4, 00001031518WK2, 00001031519WK0, 00001031520WK8, 00001031521WK6, 00001031522WK4, 00001031523WK2, 00001031524WK0, 00001031525WK7, 00001031537WK2, 00001031538WK0, 00001031539WK8, 00001031566WK1, 00001031567WK9, 00001031568WK7, 00001031569WK5, 00001031570WK3, 00001031571WK1, 00001031572WK9, 00001031573WK7, 00001031574WK5, 00001031581WK0, 00001031649WK5, 00001031650WK3, 00001031651WK1, 00001031652WK9, 00001031653WK7, 00001031654WK5, 00001031655WK2, 00001031656WK0, 00001031657WK8, 00001031658WK6, 00001031659WK4, 00001031660WK2, 00001031661WK0, 00001031662WK8, 00001031665WK1, 00001031666WK9, 00001031667WK7, 00001031669WK3, 00001031670WK1, 00001031671WK9, 00001031672WK7, 00001031673WK5, 00001031674WK3, 00001031675WK0, 00001031676WK8, 00001031677WK6, 00001031699WK0, 00001031700WK6, 00001031702WK2, 00001031703WK0, 00001031704WK8, 00001031705WK5, 00001031706WK3, 00001031711WK3, 00001031712WK1, 00001031728WK7, 00001031729WK5, 00001031730WK3, 00001031733WK7, 00001031734WK5, 00001031735WK2, 00001031738WK6, 00001031739WK4, 00001031740WK2, 00001031749WK3, 00001031750WK1, 00001031751WK9, 00001031752WK7, 00001031810WK3, 00010299771WK7.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • 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.
  • Description du dispositif
    GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems. Model numbers 5555000-5, 5555000-6, and 5421698.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • Adresse du fabricant
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Société-mère du fabricant (2017)
    General Electric Company
  • Source
    USFDA