FDA Device Recalls

Recalls /

#124760

Product

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

FDA product code
IZLSystem, X-Ray, Mobile
Device class
Class 2
Medical specialty
Radiology
510(k) numbers
K103476
Affected lot / code info
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, 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, 00001031013WK4, 00001031014WK2, 00001031017WK5, 00001031018WK3, 00001031019WK1, 00001031020WK9, 00001031021WK7, 00001031028WK2, 00001031029WK0, 00001031031WK6, 00001031032WK4, 00001031033WK2, 00001031053WK0, 00001031054WK8, 00001031055WK5, 00001031058WK9, 00001031059WK7, 00001031060WK5, 00001031061WK3, 00001031062WK1, 00001031063WK9, 00001031064WK7, 00001031108WK2, 00001031109WK0, 00001031110WK8, 00001031111WK6, 00001031112WK4, 00001031113WK2, 00001031116WK5, 00001031117WK3, 00001031118WK1, 00001031119WK9, 00001031120WK7, 00001031121WK5, 00001031122WK3, 00001031123WK1, 00001031124WK9, 00001031125WK6, 00001031153WK8, 00001031154WK6, 00001031155WK3, 00001031156WK1, 00001031157WK9, 00001031158WK7, 00001031166WK0, 00001031167WK8, 00001031168WK6, 00001031169WK4, 00001031170WK2, 00001031172WK8, 00001031173WK6, 00001031174WK4, 00001031175WK1, 00001031176WK9, 00001031177WK7, 00001031178WK5, 00001031179WK3, 00001031181WK9, 00001031206WK4, 00001031207WK2, 00001031208WK0, 00001031213WK0, 00001031214WK8, 00001031215WK5, 00001031215WK5, 00001031216WK3, 00001031219WK7, 00001031220WK5, 00001031221WK3, 00001031222WK1, 00001031226WK2, 00001031227WK0, 00001031228WK8, 00001031229WK6, 00001031235WK3, 00001031238WK7, 00001031239WK5, 00001031246WK0, 00001031247WK8, 00001031248WK6, 00001031249WK4, 00001031250WK2, 00001031251WK0, 00001031281WK7, 00001031282WK5, 00001031283WK3, 00001031284WK1, 00001031286WK6, 00001031287WK4, 00001031332WK8, 00001031334WK4, 00001031335WK1, 00001031336WK9, 00001031337WK7, 00001031338WK5, 00001031339WK3, 00001031341WK9, 00001031342WK7, 00001031343WK5, 00001031350WK0, 00001031351WK8, 00001031352WK6, 00001031353WK4, 00001031361WK7, 00001031362WK5, 00001031363WK3, 00001031386WK4, 00001031387WK2, 00001031389WK8, 00001031390WK6, 00001031391WK4, 00001031392WK2, 00001031401WK1, 00001031402WK9, 00001031403WK7, 00001031408WK6, 00001031413WK6, 00001031414WK4, 00001031415WK1, 00001031416WK9, 00001031457WK3, 00001031458WK1, 00001031459WK9, 00001031460WK7, 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.

Why it was recalled

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

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm
GE Healthcare, LLC
Address
3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

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.

Timeline

Recall initiated
2013-11-07
Posted by FDA
2014-01-11
Terminated
2014-05-06
Status

Source: openFDA Device Recall endpoint. Recall record ID #124760. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.