GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems…

Date

Jan. 22, 2014

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

GE Healthcare, LLC

Product

GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems. Model numbers 5555000-5, 5555000-6, and 5421698.

Reason

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

Distribution pattern

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.

Quantity

1027

Codes and lots

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, 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, 00001030606WK6, 00001030607WK4, 00001030617WK3, 00001030618WK1, 00001030619WK9, 00001030627WK2, 00001030628WK0, 00001030636WK3, 00001030637WK1, 00001030638WK9, 00001030654WK6, 00001030655WK3, 00001030656WK1, 00001030657WK9, 00001030660WK3, 00001030661WK1, 00001030669WK4, 00001030671WK0, 00001030672WK8, 00001030673WK6, 00001030674WK4, 00001030675WK1, 00001030736WK1, 00001030737WK9, 00001030738WK7, 00001030743WK7, 00001030744WK5, 00001030759WK3, 00001030760WK1, 00001030761WK9, 00001030762WK7, 00001030763WK5, 00001030775WK9, 00001030776WK7, 00001030777WK5, 00001030778WK3, 00001030779WK1, 00001030780WK9, 00001030781WK7, 00001030782WK5, 00001030791WK6, 00001030792WK4, 00001030793WK2, 00001030794WK0, 00001030795WK7, 00001030796WK5, 00001030797WK3, 00001030799WK9, 00001030800WK5, 00001030801WK3, 00001030802WK1, 00001030803WK9, 00001030804WK7, 00001030805WK4, 00001030806WK2, 00001030807WK0, 00001030808WK8, 00001030809WK6, 00001030810WK4, 00001030811WK2, 00001030812WK0, 00001030813WK8, 00001030814WK6, 00001030815WK3, 00001030816WK1, 00001030839WK3, 00001030840WK1, 00001030841WK9…

Recall started

Nov. 7, 2013

Device type

System, X-Ray, Mobile

Root cause (FDA)

Software design

What the company told customers

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.

Recall number

Z-0725-2014

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0725-2014. The agency record governs; check it and the company before acting.