GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3…

Date

March 26, 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 Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3. The Discovery CT 590 RT and Optima CT 580 series of Computed Tomography systems are intended to produce cross-sectional images of the body by computer reconstruction of XRay transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), and Gated (Respiratory and Cardiac) acquisitions in patients of all ages.

Reason

GE Healthcare has recently become aware of a potential safety issue due to a software issue associated with the Head Scan Protocols used on your Optima CT580 or Discovery CT590RT scanner. A potential hazardous situation may occur during a CT head scan causing a novel and rare artifact that may hide pathology. When using the head and large head SFOV, which applies the Iterative Bone Option (IBO)

Distribution pattern

Worldwide Distribution: US (nationwide) to states of: CO, IN, MA, NJ, NC, OH, PA, TX, and VA; and countries of: Algeria,France, Germany, Poland, Russia, and Taiwan.

Quantity

33 (21 US, 12 OUS)

Codes and lots

Mfg Lot or Serial # PA2314840 PA2314841 PA2314842 PA2314843 PA2314844 PA2314845 A1RF3176G A1RF3638GR A2RF1052G B1RF4038GR B3G44377G B3G44511G B3G44515G B3RF4960G C1RF4686G C1RF4793G C1RF4802G C1RF4827GR D2RF2744G D2RF2778GR D2RF2795G D2RF2796G D2RF2797G D2RF2798G D2RF2799G D2RF2814G D2RF2815G D2RF2816G D2RF2817G D2RF2818G D2RF2819G D2RF2820G D2RF2821G D2RF2822G D2RF2823G D2RF2824G D2RF2825G D2RF2826G D2RF2827G D2RF2828G D2RF2829G D2RF2830G D2RF2831G D2RF2832G D2RF2833G D2RF2834G D2RF2835G D2RF2836G D2RF2837G D2RF2838G D2RF2839G D2RF2840G D2RF2841G D2RF2842G D2RF2843G D2RF2844G D2RF2845G D2RF2846G D2RF2847G D2RF2848G D2RF2850G D2RF2851G D3G44977G D3G44983G D3G44984G D3G44985G D43T4071G D43T4072G D43T4073G D43T4074G D43T4075G D43T4076G D43T4077G E1RF5364G E1RF5479GR E1RF5480GR E1RF5599G E3RF5317G E3RF5318G F0RF0134G F0RF0135G F0RF0136G F0RF0140G F0RF0141G F1RF4827GR F1RF5952G F1RF6042GR F1RF6075GR F1RF6079GR F1RF6084GR F1RF6085GR F1RF6086GR F1RF6088GR F1RF6092GR F1RF6097GR F1RF6100GR F1RF6114GR F1RF6118GR F1RF6123GR F1RF6130GR F1RF6227GR F1RF6236G F1RF6236GR F1RF6243GR F1RF6282GR F2G40578G F2G40579G F2G40580G F2G40581G F2G40584G F2G40585G F2G40586G F2G40588G F2G40592G F2G40593G F2G40594G F2G40595G F2G40596G F2G40598G F2G40599G F2G40605G F2G40606G F2G40607G F2G40609G F2G40610G F2G40611G F2G40615G F2G40631G F2G40705G F2G40820G F2G40835G F2RF3572G F2RF3640G F2RF3651G F3G45957G F3G45980G F3G46200G F43S0355G F43S0356G G0RF0516GR G0RF0592GR G0RF0596GR G1RF6518G G1RF6544G G1RF6546G G3G46241G G3G46616G G3G46649G G3G46664G G3G46674G G3G46679G H0RF0607GR H0RF0772G H0RF0845GR H2G41289G H2G41307G H2G41571GR H2G41786G H2G41787G H2RF4002GR J0RF0465G J0RF1103G J1RF7280G J1RF7281G J1RF7282G J1RF7283G J1RF7284G J1RF7285G J1RF7286G J1RF7289G J1RF7290G J1RF7298G J1RF7387G J2G42049G J2G42100GR J33T0400G J43S0499G J43S0503G J43S0504G J43S0506G J43T5719G J43T5720G J43T5727G J43T5731G J43T5799G J43T5801G J43T5810G J43T5812G J43T5813G J43T5814G J43T5815G J43T5827G J43T5831G J43T5832G J43T5877G J43T6078G K1RF7644G K1RF7673G K1RF7674G K1RF7675G K1RF7676G K1RF7678G K1RF7679G K1RF7680G K1RF7681G K1RF7683G K1RF7704G K1RF7925GR K33T0621G K33T1002G K43T6545G L1RF8243G L1RF8254G L1RF8255G L1RF8256G L1RF8258G L1RF8259G L1RF8261G L1RF8263G L1RF8264G L1RF8265G L1RF8267G L1RF8728G L1RF8733G L2G42609G L2G42643G L2G42666G L2G42668G L2G42669G L2G42690G L2G42711G L2G42970G L2RF4373GR L33T1324G M0RF2496G M0RF2562GR M1RF9841G M2G43248G M2RF4686G M33T1729G M33T2293G PA1786357 PA1786438 PA1786439 PA1786440 PA1786441 PA1786442 PA1786443 PA1786444 PA1786445 PA1786446 PA1786447 PA1786448 PA1786449 PA1786450 PA1786451 PA1786452 PA1786453 PA1786454 PA1786456 PA1786457 PA1786458 PA1786461 PA1786462 PA1786494 PA1786495 PA1786496 PA1786497 PA1786498 PA1786499 PA1786500 PA1786501 PA1786502 PA1786503 PA1786504 PA1786505 PA1786530 PA1786531 PA1786532 PA1786533 PA1786534 PA1786535 PA1786536 PA1786537 PA1786538 PA1786539 PA1786540 PA1786541 PA1786542 PA1786543 PA1786544 PA1786545 PA1786546 PA1786547 PA1786548 PA1786549 PA1786677 PA1786678 PA1786679 PA1786680 PA1786681 PA1786682 PA1786683 PA1786684 PA1786685 PA1786686 PA1786687 PA1786688 PA1786689 PA1786690 PA1786691 PA1786692 PA1786693 PA1786694 PA1786695 PA1786696 PA1786697 PA1786698 PA1786699 PA1786700 PA1786701 PA1786702 PA1786703 PA1786704 PA1786705 PA1786706 PA1786707 PA1786708 PA1786709 PA1786710 PA1786711 PA1786712 PA1786713 PA1786714 PA1786715 PA1786716 PA1787000 PA1787001 PA1787002 PA1787003 PA1787004 PA1787005 PA1787006 PA1787007 PA1787008 PA1787009 PA1787010 PA1787011 PA1787079 PA1787080 PA1787081 PA1787082 PA1787083 PA1787084 PA1787085 PA1787086 PA1787087 PA1787088 PA1787351 PA1787352 PA1787353 PA1787354 PA1787355 PA1787356 PA1787357 PA1787478 PA1787479 PA1787480 PA1787481 PA1787482 PA1787483 PA1787484 PA1787485 PA1787561 PA1787562 PA1787563 PA1787564 PA1787565 PA1787566 PA1787567 PA1787568 PA1787569 PA1787570 PA1787571 PA1787572 PA1787573 PA1787574 PA1787575 PA1787576 PA1787577 PA1787578 PA1787579 PA1787580 PA1787581 PA1787582 PA1787583 PA1787584 PA1787585 PA1787586 PA1787587 PA1787588 PA1787589 PA1787590 PA1787591 PA1787592 PA1787593 PA1787594 PA1787595 PA1787596 PA1787597 PA1787598 PA1787599 PA1787600 PA1787601 PA1787602 PA1787603 PA1787604 PA1787605 PA1787606 PA1787607 PA1787608 PA1787609 PA1787610 PA1787611 PA1787612 PA1787613 PA1787614 PA1787615 PA1787616 PA1787617 PA1787618 PA1787619 PA1787620 PA1787621 PA1787622 PA1787623 PA1787624 PA1787625 PA1787626 PA1787627 PA1787628 PA1787629 PA1787630 PA1787631 PA1787632 PA1787633 PA1787634 PA1787635 PA1787636 PA1787637 PA1787638 PA1787639 PA1787640 PA1787641 PA1787642 PA1787643 PA1787644 PA1787645 PA1787646 PA1787647 PA1787648 PA1787649 PA1787650 PA1787651 PA1787652 PA1787653 PA1787654 PA1787655 PA1787656 PA1787657 PA1787658 PA1787659 PA1787660 PA1787661 PA1787662 PA1787663 PA1787664 PA1787665 PA1787666 PA1787667 PA1787668 PA1787669 PA1787670 PA1787671 PA1787672 PA1788113 PA1788114 PA1788115 PA1788116 PA1788117 PA1788146 PA1788147 PA1788148 PA1788149 PA1788150 PA1788151 PA1788152 PA1788153 PA1788154 PA1788155 PA1788156 PA1788157 PA1788158 PA1788159 PA1788160 PA1788161 PA1788162 PA1788163 PA1788164 PA1788165 PA1788166 PA1788167 PA1788168 PA1788169 PA1788170 PA1788171 PA1788172 PA1788173 PA1788174 PA1788175 PA1788176 PA1788177 PA1788178 PA1788179 PA1788180 PA1788310 PA1788311 PA1788312 PA1788313 PA1788314 PA1788315 PA1788316 PA1788317 PA1788318 PA1788319 PA1788320 PA1788321 PA1788322 PA1788323 PA1788324 PA1788325 PA1788326 PA1788327 PA1788328 PA1788329 PA1788330 PA1788331 PA1788332 PA1788333 PA1788334 PA1788335 PA1788336 PA1788337 PA1788338 PA1788339 PA1788360 PA1788361 PA1788362 PA1788363 PA1788364 PA1788365 PA1788366 PA1788367 PA1788368 PA1788370 PA1788371 PA1788372 PA1788373 PA1788375 PA1788378 PA1788379 PA1788380 PA1788381 PA1788382 PA1788384 PA1788407 PA1788408 PA1788409 PA1788410 PA1788411 PA1788412 PA1788413 PA1788414 PA1788415 PA1788416 PA1788417 PA1788418 PA1788419 PA1788420 PA1788421 PA1788422 PA1788423 PA1788424 PA1788425 PA1788426 PA1788427 PA1788428 PA1788429 PA1788430 PA1788431 PA1788432 PA1788433 PA1788434 PA1788435 PA1788436 PA1788471 PA1788472 PA1788473 PA1788474 PA1788475 PA1788476 PA1788477 PA1788478 PA1788479 PA1788480 PA1788481 PA1788482 PA1788483 PA1788484 PA1788485 PA1788486 PA1788487 PA1788488 PA1788489 PA1788490 PA1788491 PA1788492 PA1788493 PA1788494 PA1788495 PA1788496 PA1788497 PA1788498 PA1788499 PA1788500 PA1788501 PA1788502 PA1788503 PA1788504 PA1788505 PA1788506 PA1788507 PA1788508 PA1788509 PA1788510 PA1788511 PA1788512 PA1788513 PA1788514 PA1788515 PA1788516 PA1788517 PA1788518 PA1788519 PA1788520 PA1788521 PA1788522 PA1788523 PA1788524 PA1788525 PA1788526 PA1788527 PA1788528 PA1788529 PA1788530 PA1788531 PA1788532 PA1788533 PA1788534 PA1788535 PA1788625 PA1788626 PA1788627 PA1788628 PA1788629 PA1788630 PA1788631 PA1788632 PA1788633 PA1788634 PA1789287 PA1789288 PA1789289 PA1789290 PA1789291 PA1789292 PA1789293 PA1789294 PA1789295 PA1789296 PA1850116 PA1850117 PA1850118 PA1850119 PA1850120 PA1850121 PA1850122 PA1850123 PA1850124 PA1850125 PA1850126 PA1850127 PA1850128 PA1850129 PA1850130 PA1850131 PA1850132 PA1850133 PA1850134 PA1850135 PA1850136 PA1850137 PA1850138 PA1850139 PA1850140 PA1850141 PA1850142 PA1850143 PA1850144 PA1850145 PA1850146 PA1850147 PA1850391 PA1850392 PA1850393 PA1850394 PA1850395 PA1850396 PA1850397 PA1850398 PA1850399 PA1850400 PA1850401 PA1850402 PA1850403 PA1850404 PA1850405 PA1850406 PA1850407 PA1850408 PA1850409 PA1850410 PA1850411 PA1850412 PA1850413 PA1850414 PA1850415 PA1850416 PA1850417 PA1850418 PA1850419 PA1850420 PA1850421 PA1850422 PA1850423 PA1850424 PA1850425 PA1850426 PA1850427 PA1850428 PA1850771 PA1850772 PA1850773 PA1850774 PA1850775 PA1850776 PA1850777 PA1850778 PA1850779 PA1850791 PA1850792 PA1850793 PA1850794 PA1850795 PA1850796 PA1850797 PA1850798 PA1850897 PA1850898 PA1850899 PA1850900 PA1850901 PA1850902 PA1850903 PA1850904 PA1850905 PA1850906 PA1850907 PA1850908 PA1850909 PA1850910 PA1850911 PA1850912 PA1850913 PA1850914 PA1850915 PA1850916 PA1850917 PA1850918 PA1850919 PA1850920 PA1850921 PA1850922 PA1850923 PA1850924 PA1850925 PA1850926 PA1850927 PA1850928 PA1850929 PA1850930 PA1850931 PA1851412 PA1851413 PA1851414 PA1851415 PA1851416 PA1851829 PA1851830 PA1851831 PA1851832 PA1851833 PA1851834 PA1851835 PA1851836 PA1851837 PA1851838 PA1851839 PA1851840 PA1851841 PA1851842 PA1851843 PA1851844 PA1852084 PA1852085 PA1852086 PA1852087 PA1852088 PA1852089 PA1852090 PA1852091 PA1852092 PA1852093 PA1852094 PA1852095 PA1852096 PA1852097 PA1852098 PA1852099 PA1852138 PA1852139 PA1852140 PA1852141 PA1852142 PA1852143 PA1852144 PA1852145 PA1852146 PA1852147 PA1852148 PA1852149 PA1852150 PA1852151 PA1852152 PA1852153 PA1852154 PA1852155 PA1852156 PA1852157 PA1852158 PA1852159 PA1852160 PA1852161 PA1852162 PA1852163 PA1852164 PA1852165 PA1852166 PA1852167 PA1852168 PA1852169 PA1852170 PA1852171 PA1852172 PA1852173 PA1852174 PA1852175 PA1852176 PA1852177 PA1852178 PA1852179 PA1852180 PA1852181 PA1852182 PA1852183 PA1852184 PA1852185 PA1852186 PA1852187 PA1852188 PA1852189 PA1852190 PA1852191 PA1852192 PA1852193 PA1852194 PA1852195 PA1852196 PA1852197 PA1852198 PA1852199 PA1852200 PA1852201 PA1852202 PA1852203 PA1852204 PA1852205 PA1852206 PA1852207 PA1852208 PA1852209 PA1852210 PA1852211 PA1852212 PA1852213 PA1852214 PA1852215 PA1852216 PA1852217 PA1852218 PA1852219 PA1852220 PA1852221 PA1852222 PA1852223 PA1852224 PA1852225 PA1852226 PA1852227 PA1852228 PA1852229 PA1852230 PA1852231 PA1852232 PA1852233 PA1852234 PA1852235 PA1852236 PA1852237 PA1852409 PA1852410 PA1852411 PA1852412 PA1852413 PA1852414 PA1852415 PA1852416 PA1852417 PA1852418 PA1852419 PA1852420 PA1852421 PA1852422 PA1852423 PA1852424 PA1852425 PA1852426 PA1852427 PA1852428 PA1852429 PA1852430 PA1852431 PA1852432 PA1852433 PA1852434 PA1852435 PA1852436 PA1852437 PA1852438 PA1852439 PA1852440 PA1852441 PA1852442 PA1852443 PA1852444 PA1852445 PA1852446 PA1852447 PA1852448 PA1852449 PA1852808 PA1852809 PA1852810 PA1852811 PA1852812 PA1852813 PA1852814 PA1852815 PA1852816 PA1852817 PA1852818 PA1852819 PA1852820 PA1852821 PA1852822 PA1852823 PA1852824 PA1854656 PA1854657 PA1854658 PA1854659 PA1854660 PA1854661 PA1895455 PA1895456 PA1895457 PA1895458 PA1897813 PA1990824 PA1990825 PA1990826 PA1990827 PA1990828 PA1990829 PA1990830 PA1990831 PA1990832 PA1990833 PA1990834 PA1990835 PA1990836 PA1990837 PA1990838 PA1990839 PA1990840 PA1991403 PA1991404 PA1991405 PA1991406 PA1991407 PA1991408 PA1991409 PA1991410 PA1991411 PA1991412 PA1991413 PA1991414 PA1991415 PA1991416 PA1991417 PA1991418 PA1991419 PA1991440 PA1991442 PA1991635 PA1991851 PA1991852 PA1991853 PA1991854 PA1991855 PA1991856 PA1991857 PA1991858 PA1991859 PA1991860 PA1991861 PA1991862 PA1991863 PA1991864 PA1991865 PA1991866 PA1991867 PA1991868 PA1991869 PA1991870 PA1992005 PA1992006 PA1992007 PA1992008 PA1992112 PA1992113 PA1992114 PA1992115 PA1992116 PA1992117 PA1992118 PA1992119 PA1992120 PA1992121 PA1992122 PA1992123 PA1992124 PA1992125 PA1992126 PA1992127 PA1993645 PA1993646 PA1993647 PA1993648 PA1993649 PA1993650 PA1993651 PA1993652 PA1993653 PA1993654 PA1993655 PA1993656 PA1993657 PA1993658 PA1993659 PA1993660 PA1993661 PA1993662 PA1993663 PA1993664 PA1993665 PA1993666 PA1993667 PA1993668 PA1993860 PA1993861 PA1993862 PA1993863 PA1993864 PA1993865 PA1993866 PA1994201 PA1994202 PA1994203 PA1994204 PA1994205 PA2007158 PA2007159 PA2007160 PA2007161 PA2007162 PA2007163 PA2020375 PA2020376 PA2020377 PA2020378 PA2020379 PA2020380 PA2020381 PA2020382 PA2020383 PA2020384 PA2020385 PA2020386 PA2020387 PA2020388 PA2020389 PA2020390 PA2020391 PA2020392 PA2020458 PA2020459 PA2020460 PA2020461 PA2020462 PA2020463 PA2020464 PA2020465 PA2020466 PA2020467 PA2020468 PA2020469 PA2020470 PA2020471 PA2020472 PA2020473 PA2020474 PA2020475 PA2020476 PA2020477 PA2020478 PA2020479 PA2020480 PA2020481 PA2020482 PA2020505 PA2020506 PA2020507 PA2020508 PA2020509 PA2020510 PA2020511 PA2020512 PA2020513 PA2020514 PA2020515 PA2020516 PA2020517 PA2020518…

Recall started

Feb. 14, 2014

Device type

System, X-Ray, Tomography, Computed

Root cause (FDA)

Software design

What the company told customers

The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated February 14, 2014 to its Consignees. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Directors and Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. The consignees were instructed to ensure that all potential users in your facility are made aware of this safety notification and recommended actions. A GE Healthcare Service representative will perform the required software update on each affected system. This activity will be performed at no cost to consignees. Please contact your local GE Healthcare Service Representative if you have any questions or concerns regarding this notification. You may also contact GE Healthcare Call Center: United States or Canada: 800-437-1171 and in other countries, please contact your local GE Healthcare Service Representative.

Recall number

Z-1245-2014

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

Source: FDA · Medical device enforcement report, recall number Z-1245-2014. The agency record governs; check it and the company before acting.