Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall CASE Cardiac Testing System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall CASE Cardiac Testing Systemsee related information
Date Initiated by FirmApril 24, 2026
Date PostedJune 01, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2279-2026
Recall Event ID 98932
510(K)NumberK231870 
Product Classification Computer, diagnostic, programmable - Product Code DQK
ProductCASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3
Code Information UDI-DI 00195278617644 Serial numbers SU325232838SA SU325032272SA SU325293027SA SU325222794SA SU325122553SA SU325363223SA SU325483517SA SU325152591SA SU325363222SA SU325483514SA SU325272955SA SU325222809SA SU325092421SA SU325272941SA SU325272944SA SU325393292SA SU325393293SA SU325393296SA SU325443415SA SU325303053SA SU325353201SA SU324512241SA SU325032260SA SU325433377SA SU325242899SA SU325242900SA SU325192689SA SU325172624SA SU325172626SA SU325172630SA SU325333173SA SU325383266SA SU324502188SA SU325112523SA SU325112524SA SU325192719SA SU325313091SA SU325403321SA SU325323101SA SU325323103SA SU324502193SA SU324502203SA SU324502209SA SU324502211SA SU325272960SA SU325272962SA SU325252906SA SU325433376SA SU325473497SA SU324502191SA SU324502204SA SU324502206SA SU324502207SA SU325293013SA SU325293014SA SU325293015SA SU325293016SA SU325383265SA SU324482168SA SU325122538SA SU325122540SA SU325192691SA SU325192692SA SU325192708SA SU324492172SA SU325172632SA SU325182669SA SU325323135SA SU325323137SA SU325503570SA SU326033668SA SU325172613SA SU325052318SA SU325373241SA SU325443399SA SU325222802SA SU325222803SA SU325222805SA SU325293025SA SU325272954SA SU324512242SA SU325132576SA SU325172612SA SU325172614SA SU325172640SA SU325172641SA SU325192693SA SU325252910SA SU325092412SA SU325333171SA SU325122543SA SU325182687SA SU325242868SA SU325242870SA SU325473487SA SU326023667SA SU325062342SA SU325473493SA SU325252909SA SU325282987SA SU325293020SA SU325473494SA SU325473495SA SU326033696SA SU326033700SA SU326033701SA SU325463458SA SU325463461SA SU324502190SA SU325042274SA SU325122539SA SU325122541SA SU325192707SA SU325192710SA SU325192711SA SU325192717SA SU325192721SA SU325293017SA SU325293018SA SU325343185SA SU325343186SA SU325493541SA SU325493543SA SU325493549SA SU325052306SA SU325222771SA SU325222777SA SU325222778SA SU325222783SA SU325222797SA SU325493536SA SU325493539SA SU325313066SA SU325313067SA SU325313068SA SU325333167SA SU325333168SA SU325333170SA SU325403315SA SU325403318SA SU325112516SA SU325443403SA SU325122547SA SU325473486SA SU325303059SA SU325313095SA SU325313096SA SU325313098SA SU325433378SA SU325513591SA SU325353194SA SU325192694SA SU325192697SA SU325483518SA SU325252905SA SU325493558SA SU325222768SA SU324492183SA SU324492184SA SU324502185SA SU325503568SA SU325513589SA SU325282989SA SU325282991SA SU325282992SA SU325463466SA SU325473496SA SU325182655SA SU325032267SA SU325313075SA SU325413336SA SU325282996SA SU325172643SA SU325042285SA SU325293024SA SU325523609SA SU325523610SA SU325523611SA SU325363217SA SU325363219SA SU325112508SA SU325162594SA SU325072361SA SU325072362SA SU325373248SA SU325202734SA SU325443397SA SU325443398SA SU326053735SA SU324492181SA SU325192700SA SU325222806SA SU325443392SA SU325242869SA SU325242887SA SU325242890SA SU325052292SA SU325052295SA SU325072383SA SU325072384SA SU325092414SA SU325092417SA SU325152592SA SU325313089SA SU325313090SA SU325403330SA SU325423361SA SU325423366SA SU325042284SA SU325383253SA SU325172609SA SU325182650SA SU325323128SA SU325293021SA SU325132574SA SU325142587SA SU325142589SA SU325192701SA SU325192703SA SU325222786SA SU325293023SA SU325282986SA SU325192715SA SU325272957SA SU325272958SA SU326063754SA SU325473492SA SU325092409SA SU325393290SA SU325463479SA SU325463480SA SU325463459SA SU326033702SA SU325182657SA SU325282981SA SU325423364SA SU325182685SA SU325232811SA SU325172595SA SU325172607SA SU325072352SA SU325092423SA SU325252907SA SU325363225SA SU325072360SA SU325293031SA SU325463460SA SU325463462SA SU325222784SA SU325222787SA SU324482166SA SU325042281SA SU325323125SA SU325323126SA SU325423363SA SU326053734SA SU325202747SA SU325202749SA SU325232816SA SU325323121SA SU325293033SA SU325042273SA SU325192716SA SU325112515SA SU325112520SA SU325182670SA SU325473488SA SU325182646SA SU325363213SA SU325363218SA SU325383254SA SU325042278SA SU325252911SA SU325052320SA SU325242895SA SU325373245SA SU326023636SA SU325052315SA SU325433368SA SU325453442SA SU325453443SA SU325513596SA SU325463457SA SU325242894SA SU325363229SA SU325363235SA SU325463454SA SU325463455SA SU325463456SA SU325363220SA SU325313081SA SU325443393SA SU325353200SA SU326063745SA SU325222801SA SU325042275SA SU325433375SA SU325172616SA SU325172617SA SU324512243SA SU324512244SA SU325282983SA SU325313092SA SU325032266SA SU325202743SA SU325092416SA SU324512248SA SU326033691SA SU325102453SA SU325102455SA SU325102456SA SU325112482SA SU325112484SA SU325112486SA SU325112488SA SU325112489SA SU325112509SA SU325112512SA SU325112517SA SU325112518SA SU325112519SA SU325202763SA SU325222769SA SU325242871SA SU325282995SA SU325313076SA SU325393285SA SU325333154SA SU325333156SA SU325473504SA SU325293034SA SU325293035SA SU325232832SA SU325443390SA SU325142586SA SU326043719SA SU325483507SA SU325483509SA SU325483511SA SU325463473SA SU325092443SA SU326033672SA SU325172642SA SU325182660SA SU325523616SA SU325393300SA SU325272951SA SU325313097SA SU325443389SA SU326063755SA SU326063756SA SU326063757SA SU325323106SA SU325323109SA SU325222796SA SU325222799SA SU325232819SA SU325232823SA SU325232824SA SU325232826SA SU325282993SA SU325172627SA SU325393298SA SU324502201SA SU325122549SA SU325172597SA SU325172598SA SU326023663SA SU325252923SA SU324502189SA SU325463468SA SU325463469SA SU325463470SA SU325323116SA SU325323118SA SU325232825SA SU325112507SA SU325252912SA SU325252914SA SU325252916SA SU325112521SA SU325483506SA SU325122550SA SU325032270SA SU325353199SA SU325112506SA SU325112510SA SU325112513SA SU325323112SA SU325333155SA SU325513593SA SU325122532SA SU325122535SA SU325122537SA SU325122542SA SU325242867SA SU325483534SA SU325072366SA SU325343178SA SU326063751SA SU325172635SA SU325222798SA SU325052311SA SU325052312SA SU325052313SA SU325042288SA SU324522256SA SU325293028SA SU325513605SA SU325333175SA SU325493551SA SU325493552SA SU325493553SA SU325493554SA SU325393288SA SU325333158SA SU325393295SA SU325393283SA SU326023662SA SU325483530SA SU325483531SA SU325393289SA SU325473481SA SU325222780SA SU325393284SA SU325222790SA SU325172625SA SU325192722SA SU325192723SA SU325222788SA SU325262939SA SU325262940SA SU325272942SA SU325132560SA SU325323131SA SU325323133SA SU325443406SA SU325443412SA SU325443414SA SU325132568SA SU325242879SA SU326053732SA SU326043726SA SU325473485SA SU325072381SA SU324502202SA SU325493565SA SU325513603SA SU325513604SA SU326043728SA SU325112494SA SU325122527SA SU325132583SA SU324472143SA SU326043720SA SU326043722SA SU326053737SA SU326053738SA SU326053739SA SU326053740SA SU326043724SA SU325343181SA SU326053741SA SU325272949SA SU325483528SA SU325483532SA SU325483533SA SU325483535SA SU325503573SA SU325272945SA SU325423355SA SU325232843SA SU325232846SA SU325232821SA SU325232836SA SU325232837SA SU325443388SA SU325443391SA SU325443394SA SU325252920SA SU325072358SA SU325132575SA SU325072372SA SU325453440SA SU325232841SA SU325252919SA SU325443408SA SU325443410SA SU325313072SA SU325433384SA SU325433386SA SU325483524SA SU324502196SA SU325242897SA SU325242898SA SU325232839SA SU325513607SA SU325513608SA SU324502215SA SU325132561SA SU325132562SA SU325132563SA SU325132565SA SU325132567SA SU325132570SA SU325132572SA SU326033698SA SU325022258SA SU325453448SA SU325333157SA SU325403320SA SU325433367SA SU325333161SA SU325122551SA SU325172599SA SU325293029SA SU325293030SA SU324462137SA SU324462138SA SU325182677SA SU325262936SA SU325403331SA SU325403332SA SU326033697SA SU326033699SA SU325453438SA SU325463464SA SU325463465SA SU324502229SA SU325343179SA SU325172604SA SU325453420SA SU324472147SA SU326033704SA SU325072367SA SU325172621SA SU325453418SA SU325132584SA SU325453421SA SU325032268SA SU325092413SA SU325282985SA SU326063749SA SU325172619SA SU325052314SA SU325172620SA SU325443387SA SU325182686SA SU325192690SA SU325202737SA SU325202740SA SU325202741SA SU325202742SA SU325262937SA SU325282984SA SU325172596SA SU325373247SA SU325373249SA SU325072350SA SU324502228SA SU325433370SA SU325433373SA SU325202764SA SU325202765SA SU325202766SA SU325032271SA SU325272959SA SU325272961SA SU325272977SA SU325272978SA SU325272979SA SU325282980SA SU325493563SA SU326053733SA SU325112483SA SU325323117SA SU325323119SA SU325323120SA SU325313071SA SU325142590SA SU325072354SA SU325242896SA SU325252901SA SU325252902SA SU325252903SA SU325252904SA SU325323136SA SU325323138SA SU326033689SA SU325493547SA SU325423362SA SU325112490SA SU325092419SA SU325282994SA SU325323132SA SU325323134SA SU325272974SA SU325272975SA SU325272976SA SU325282998SA SU325092444SA SU324512245SA SU325192706SA SU325333165SA SU325483523SA SU325483525SA SU324502199SA SU325513595SA SU325343188SA SU325383251SA SU325383252SA SU325222804SA SU325222807SA SU325192714SA SU325513600SA SU325393274SA SU325222800SA SU325042287SA SU325373244SA SU325383268SA SU326023638SA SU324512240SA SU325242893SA SU325383269SA SU326023632SA SU326023633SA SU325393303SA SU326023661SA SU325393286SA SU325042276SA SU325042277SA SU325313086SA SU325313077SA SU325313083SA SU325202731SA SU325393299SA SU325393301SA SU325333160SA SU325493545SA SU325323122SA SU325323123SA SU325323124SA SU325272956SA SU325242857SA SU325242860SA SU325222782SA SU325222785SA SU325202745SA SU325483516SA SU325072353SA SU325072376SA SU325092410SA SU325132554SA SU325132555SA SU325172615SA SU325172618SA SU325393272SA SU325393273SA SU325393276SA SU325393278SA SU325403316SA SU325403317SA SU326023635SA SU325172623SA SU325202744SA SU325202746SA SU325343187SA SU325383263SA SU325363215SA SU325383261SA SU325383267SA SU325383270SA SU325383271SA SU325393275SA SU325192718SA SU325333163SA SU325333164SA SU325333166SA SU324502220SA SU325493544SA SU326033687SA SU325252908SA SU325483519SA SU325483521SA SU325112495SA SU325112497SA SU325122552SA SU325303050SA SU325142585SA SU325363210SA SU325182678SA SU325182679SA SU325182681SA SU325182683SA SU325222810SA SU325232814SA SU325232817SA SU325122534SA SU325242881SA SU325333159SA SU325333162SA SU325363204SA SU325363205SA SU325363207SA SU325363209SA SU325363211SA SU325433374SA SU325232812SA SU325232813SA SU325232815SA SU325112522SA SU325252924SA SU325252927SA SU325393277SA SU325453423SA SU325513606SA SU325483505SA SU325483508SA SU325483510SA SU325483512SA SU325122531SA SU325323130SA SU325513602SA SU325072357SA SU325242891SA SU325242892SA SU324472139SA SU324472140SA SU325122533SA SU325122536SA SU325122530SA SU325122544SA SU325122546SA SU325513590SA SU325172629SA SU325433379SA SU324462134SA SU326063753SA SU325503572SA SU324422120SA SU325242855SA SU325403314SA SU325413338SA SU325172644SA SU325112485SA SU325102479SA SU324502200SA SU325112504SA SU325242888SA SU325112491SA SU325293026SA SU324492173SA SU324492174SA SU324492177SA SU324492179SA SU325102447SA SU325112493SA SU325112505SA SU325112481SA SU324502192SA SU325202748SA SU325272943SA SU325323113SA SU325323115SA SU325433369SA SU325433371SA SU325433372SA SU325383250SA SU325473491SA SU325232842SA SU325232847SA SU324512251SA SU324512253SA SU324512255SA SU325323114SA SU325192704SA SU325423359SA SU325423360SA SU325423365SA SU325232830SA SU325282982SA SU325242866SA SU325222770SA SU325192702SA SU325423356SA SU326033683SA SU325513601SA SU326023664SA SU326023666SA SU325132564SA SU325132578SA SU325132579SA SU325132580SA SU325132581SA SU325132582SA SU325172601SA SU326043718SA SU325403324SA SU325283002SA SU325102477SA SU325242877SA SU325182645SA SU325313074SA SU325192695SA SU325192698SA SU326053731SA SU325423357SA SU325252913SA SU325463471SA SU325463472SA SU325493555SA SU325182682SA SU325182684SA SU325112492SA SU325323100SA SU325323102SA SU325403326SA SU325403327SA SU325353195SA SU325353196SA SU325353197SA SU325353198SA SU325333172SA SU325333174SA SU325202736SA SU325252917SA SU325252918SA SU325252921SA SU325232818SA SU324482150SA SU325092415SA SU325182674SA SU325282990SA SU325523613SA SU325072349SA SU325092428SA SU325102476SA SU325242856SA SU325052291SA SU325052293SA SU325232831SA SU325313082SA SU325423348SA SU324502219SA SU325293012SA SU325453449SA SU325483527SA SU325102480SA SU325112487SA SU326033705SA SU325062326SA SU325072356SA SU325072392SA SU325313085SA SU325313087SA SU325323110SA SU325323129SA SU325363214SA SU325383260SA SU325423352SA SU325042283SA SU325182673SA SU324512247SA SU325262931SA SU325262932SA SU325072369SA SU325072371SA SU325072374SA SU325112511SA SU325112514SA SU324462136SA SU325513586SA SU324502205SA SU325242883SA SU325473483SA SU325493564SA SU325142588SA SU324472141SA SU324472142SA SU324472149SA SU325042289SA SU325042290SA SU325202738SA SU325202752SA SU325202753SA SU325272946SA SU325483515SA SU325252915SA SU326023631SA SU325222795SA SU325343180SA SU325172634SA SU324522257SA SU325483520SA SU325202733SA SU325052307SA SU325523612SA SU325182656SA SU324502225SA SU325052319SA SU325052317SA SU325182658SA SU325313079SA SU325313080SA SU325293011SA SU325242852SA SU325192720SA SU325272952SA SU325473490SA SU325343176SA SU325313073SA SU325493556SA SU325393302SA SU325463463SA SU325423347SA SU324502187SA SU325102448SA SU325102449SA SU325122548SA SU325092418SA SU325032269SA SU325232827SA SU325232829SA SU324502194SA SU324502195SA SU325463467SA SU324492182SA SU325132556SA SU325132557SA SU325132558SA SU325092445SA SU325513584SA SU325513588SA SU325493548SA SU325313094SA SU325383256SA SU325383258SA SU325122529SA SU325483513SA SU325092411SA SU325112499SA SU325473484SA SU325232835SA SU325052308SA SU325242858SA SU325313093SA SU325373239SA SU326033703SA SU325182675SA SU325182676SA SU325443395SA SU325443396SA SU325272948SA SU324502221SA SU324502222SA SU324502223SA SU324502224SA SU324502226SA SU324502227SA SU325122528SA SU325383259SA SU325383262SA SU325383264SA SU325443400SA SU325443401SA SU325493550SA SU325383255SA SU325363221SA SU325453417SA SU325192688SA SU326063750SA SU325192696SA SU325042280SA SU325383257SA SU325443402SA SU325293019SA SU325293022SA SU325323139SA SU325051003SA SU325351141SA SU324482169SA SU325303058SA SU325403323SA SU325242864SA SU325102446SA SU325303061SA SU324502218SA SU324472148SA SU324482167SA SU325232820SA SU325232822SA SU325072363SA SU325222791SA SU325202751SA SU324392113SA SU325232828SA SU324482170SA SU325423351SA SU325423353SA SU325293039SA SU324462128SA SU324462131SA SU325333169SA SU325423358SA SU324462127SA SU325313078SA SU325393294SA SU325232834SA SU324502217SA SU324512254SA SU325102451SA SU325192705SA SU325192709SA SU325272950SA SU325313099SA SU325413346SA SU325423354SA SU325503571SA SU325072390SA SU325092420SA SU324512252SA SU325092424SA SU325151040SA SU325381180SA SU325272953SA SU325363208SA SU325132566SA SU325132569SA SU325132571SA SU325132573SA SU325363206SA SU325052309SA SU325102452SA SU325473498SA SU325303060SA SU325313088SA SU325072355SA SU326023651SA SU325062325SA SU325092422SA SU325483522SA SU325172638SA SU325062329SA SU325172639SA SU325323111SA SU325373243SA SU325483529SA SU325092433SA SU324502197SA SU324502230SA SU325042279SA SU325042282SA SU325112496SA SU325112498SA SU325112500SA SU325112502SA SU325092434SA SU324502208SA SU324502210SA SU325493557SA SU325493559SA SU325493561SA SU325493566SA SU325353193SA SU325363212SA SU324482162SA SU324482159SA SU324482165SA SU324482157SA SU324482163SA SU324482151SA SU324482152SA SU324482153SA SU324482158SA SU324482160SA SU324482164SA SU324482154SA SU324482156SA SU324482161SA SU324482155SA SU325363216SA SU326023617SA SU325102450SA SU325102478SA SU325513585SA SU325513587SA SU325122545SA SU326023624SA SU325393280SA SU324512246SA SU325393287SA SU325423350SA SU325072351SA SU325202750SA SU325152593SA SU325242854SA SU325363230SA SU325363231SA SU325363232SA SU325363233SA SU325363234SA SU325363236SA SU325363238SA SU325453439SA SU325453441SA SU325453444SA SU325453445SA SU325453446SA SU325453447SA SU325202735SA SU325453426SA SU325122526SA SU324502198SA SU325112501SA SU325363237SA SU325483526SA SU325132559SA SU324512239SA SU325473482SA SU324512249SA SU325202732SA SU325232833SA SU325042286SA SU325072365SA SU325242865SA SU325393281SA SU325303056SA SU325303057SA SU325102454SA SU325262938SA SU325272947SA SU325192699SA SU325393291SA SU325141024SA SU325141033SA SU325141034SA SU325141035SA SU325331131SA SU324402118SA SU325172600SA SU324402117SA SU323462000SA SU324210009SA SU324210011SA SU325191059SA SU325092431SA SU324492175SA SU325361154SA SU324352107SA SU325172605SA SU325172608SA SU325182653SA SU325172602SA SU324210001SA SU325182654SA SU325082407SA SU324460002SA SU324320001SA SU324010004SA SU324210002SA SU325371175SA SU323481008SA SU324481007SA SU324340003SA SU324010007SA SU325032261SA SU325493538SA SU324010005SA SU324210010SA SU324222081SA SU325202726SA SU324481000SA SU325371167SA SU324350004SA SU325172603SA SU325182664SA SU325202725SA SU324082050SA SU324212076SA SU325222773SA SU325222776SA SU325242862SA SU325191063SA SU325513599SA SU323481009SA SU325341136SA SU325182662SA SU324350002SA SU325202758SA SU325341138SA SU324272087SA SU325301109SA SU324342093SA SU324460001SA SU324462125SA SU324210007SA SU324460004SA SU324072048SA SU324210006SA SU324462124SA SU324492180SA SU324502216SA SU324010006SA SU324350008SA SU325092430SA SU325092436SA SU323511015SA SU325141032SA SU324402116SA SU325202727SA SU325242876SA SU325221078SA SU325202756SA SU325182665SA SU325202730SA SU324460003SA SU325201075SA SU325041000SA SU325082404SA SU325082406SA SU325091010SA SU324471001SA SU324481011SA SU325061000SA SU325172622SA SU325182659SA SU325242872SA SU325242873SA SU325463474SA SU325463475SA SU325463476SA SU325463477SA SU325463478SA SU325102469SA SU325453435SA SU325463453SA SU325072364SA SU325232844SA SU325272969SA SU325272971SA SU325282997SA SU325403325SA SU325403329SA SU325172633SA SU325182647SA SU325102457SA SU325293036SA SU325232848SA SU325182649SA SU325232845SA SU325202762SA SU324512234SA SU324512236SA SU325272963SA SU325272968SA SU325272970SA SU325303046SA SU325303047SA SU325303051SA SU325443405SA SU325463451SA SU325102463SA SU325232840SA SU325102458SA SU325102465SA SU325102466SA SU325303043SA SU325303044SA SU325303049SA SU325453434SA SU325072370SA SU325072368SA SU325172628SA SU325293042SA SU325373242SA SU325182651SA SU325232850SA SU325293032SA SU325172637SA SU324512235SA SU325102474SA SU325453432SA SU324512250SA SU325172636SA SU325303055SA SU325453419SA SU325453422SA SU324512233SA SU325463452SA SU325102471SA SU325453416SA SU325272965SA SU325293040SA SU325293041SA SU325072373SA SU324512238SA SU325303048SA SU325303045SA SU325303052SA SU325232851SA SU324512237SA SU325272972SA SU325232849SA SU325293038SA SU325443404SA SU325272973SA SU325072375SA SU325182648SA SU325293037SA SU325453431SA SU325453436SA SU325453437SA SU325373240SA SU325272966SA SU325453429SA SU325102470SA SU325463450SA SU325182652SA SU325102467SA SU325453424SA SU325453425SA SU325172631SA SU325272967SA SU325453430SA SU325102475SA SU325242880SA SU325242882SA SU325242884SA SU325242885SA SU325242886SA SU325102472SA SU325102473SA SU325102468SA SU325202760SA SU325282988SA SU326023654SA SU325303054SA SU325453428SA SU325321129SA SU325393297SA SU325443413SA SU324502231SA SU324502232SA SU325052296SA SU325052297SA SU325052298SA SU325052299SA SU325052300SA SU325052301SA SU325052302SA SU325052303SA SU325052304SA SU325052305SA SU325062330SA SU325062331SA SU325062332SA SU325062333SA SU325062334SA SU325062335SA SU325062336SA SU325062337SA SU325062338SA SU325062339SA SU325062340SA SU325062341SA SU325272964SA SU325282999SA SU325283001SA SU325283003SA SU325283004SA SU325283005SA SU325283006SA SU325283007SA SU325283008SA SU325283009SA SU325283010SA SU325333140SA SU325333141SA SU325333142SA SU325333143SA SU325333144SA SU325333145SA SU325333146SA SU325333147SA SU325333148SA SU325333149SA SU325413333SA SU325413334SA SU325413335SA SU325413337SA SU325413339SA SU325433380SA SU325433381SA SU325433382SA SU325433383SA SU325433385SA SU325503579SA SU325503580SA SU325503581SA SU325503582SA SU325503583SA SU325062343SA SU325062344SA SU325062345SA SU325062346SA SU325062347SA SU325062348SA SU324212075SA SU325513592SA SU325301108SA SU325202754SA SU324320002SA SU325032263SA SU323462003SA SU325092427SA SU324212073SA SU325102459SA SU325102460SA SU324272085SA SU324272086SA SU325361145SA SU324350001SA SU325351140SA SU323461003SA SU323482009SA SU324471000SA SU324481004SA SU324481003SA SU323481007SA SU324210003SA SU323482010SA SU324342102SA SU325191064SA SU324212078SA SU325241086SA SU324330001SA SU325161057SA SU323110003SA SU325111012SA SU325141038SA SU324481002SA SU323121000SA SU323461002SA SU325331130SA SU325331132SA SU323121001SA SU324481006SA SU325191061SA SU325191065SA SU323481010SA SU323511014SA SU325161053SA SU324342106SA SU324481001SA SU324501001SA SU325361149SA SU324342101SA SU325062327SA SU325062328SA SU325291107SA SU325471220SA SU325261099SA SU325351142SA SU325471226SA SU325521242SA SU325391186SA SU325471221SA SU325321124SA SU325431198SA SU325291106SA SU325391185SA SU325251094SA SU325431197SA SU325231084SA SU325311123SA SU325501227SA SU325241085SA SU325401187SA SU325251095SA SU325182661SA SU325182667SA SU325301110SA SU325151041SA SU325151043SA SU325151044SA SU325151045SA SU325151046SA SU325411190SA SU325411191SA SU325411192SA SU325411193SA SU325411194SA SU325501228SA SU325501229SA SU325501230SA SU325501231SA SU325501232SA SU324521000SA SU324521001SA SU324521002SA SU324521003SA SU324521004SA SU324521005SA SU324521006SA SU325081000SA SU325081001SA SU325081002SA SU325081004SA SU325081006SA SU325081007SA SU325081009SA SU325081012SA SU325081015SA SU325081016SA SU325111016SA SU325111017SA SU325121018SA SU325121019SA SU325121020SA SU325311119SA SU324212071SA SU324342096SA SU324342097SA SU324422122SA SU324222080SA SU325343191SA SU325343192SA SU324232082SA SU324272083SA SU325323108SA SU325333150SA SU325132577SA SU325222772SA SU325222779SA SU325222781SA SU325182668SA SU325182671SA SU325182672SA SU325242874SA SU325082402SA SU325262933SA SU325262934SA SU325032265SA SU325403319SA SU325052294SA SUU24480256SA SU325202724SA SU325421195SA SU325421196SA SU325461216SA SU325461217SA SU325461218SA SU325461219SA SU325371172SA SU325371174SA SU324460005SA SU324501006SA SU324501003SA SU325191072SA SU325141030SA SU325221080SA SU325341139SA SU325221082SA SU325221083SA SU325331133SA SU325191067SA SU325291105SA SU325201076SA SU325221081SA SU325111013SA SU325141022SA SU325141026SA SU325291104SA SU325361143SA SU325361153SA SU324481009SA SU325251093SA SU325291102SA SU325361152SA SU324501002SA SU324481010SA SU324501004SA SU325251092SA SU325251096SA SU325341137SA SU325371176SA SU325391184SA SU325221079SA SU325341134SA SU325151039SA SU325111015SA SU325261098SA SU325311120SA SU325521241SA SU325081018SA SU325091000SA SU325091001SA SU325081008SA SU325151042SA SU325201077SA SU325461215SA SU325081017SA SU325081014SA SU325081013SA SU325161054SA SU325291103SA SU324350006SA SU324342098SA SU324212068SA SU325091008SA SU325361144SA SU324472144SA SU324340002SA SU324082054SA SU325081005SA SU324352109SA SU324472145SA SU324472146SA SU325072394SA SU325072397SA SU325141036SA SU325323105SA SU325451205SA SU325361147SA SU325102462SA SU325371155SA SU325082408SA SU325141037SA SU324352108SA SU325161055SA SU325503569SA SU325503576SA SU325503577SA SU324082058SA SU325182666SA SU323482005SA SU323512016SA SU323512017SA SU325411188SA SU325411189SA SU325061001SA SU325021000SA SU325101011SA SU325171058SA SU325071000SA SU325242861SA SU325242863SA SU325061002SA SU325061003SA SU325061004SA SU325061005SA SU325061006SA SU325061007SA SU325071001SA SU325071002SA SU325071003SA SU325072377SA SU325072378SA SU325072379SA SU325072380SA SU325072382SA SU325072385SA SU325072386SA SU325072387SA SU325072388SA SU325072389SA SU325252925SA SU325252926SA SU325252928SA SU325252929SA SU325252930SA SU325403304SA SU325403305SA SU325403306SA SU325403307SA SU325403308SA SU325403309SA SU325403310SA SU325403311SA SU325403312SA SU325403313SA SU325082401SA SU324481005SA SU324501005SA SU325041001SA SU325051002SA SU325091002SA SU325091004SA SU325091005SA SU325091006SA SU325091007SA SU325141023SA SU325141027SA SU325141031SA SU325161051SA SU325161052SA SU325161056SA SU325241087SA SU325241088SA SU325241089SA SU325241090SA SU325341135SA SU325451202SA SU325451203SA SU325091003SA SU325081011SA SU325141028SA SU324342095SA SU324350005SA SU324350009SA SU325051001SA SU325081003SA SU325081010SA SU325191060SA SU325191068SA SU325191071SA SU325191073SA SU325301111SA SU325301112SA SU325321125SA SU325321127SA SU325361148SA SU325361150SA SU325371158SA SU325371159SA SU325371160SA SU325371161SA SU325371162SA SU325371163SA SU325371164SA SU325371166SA SU325371168SA SU325371169SA SU325451200SA SU325451201SA SU325091009SA SU325201074SA SU325102461SA SU325111014SA SU325141021SA SU325141025SA SU325141029SA SU324210004SA SU324210005SA SU324210008SA SU324210012SA SU324340001SA SU324350003SA SU324350007SA SU324350010SA SU324350011SA SU324350012SA SU324360002SA SU325191069SA SU325191070SA SU325251097SA SU325321126SA SU325321128SA SU325371156SA SU325371157SA SU325051000SA SU325451199SA SU325172610SA SU325072399SA SU325082405SA SU324010002SA SU324492178SA SU323511013SA SU325092441SA SU325092442SA SU325242859SA SU325503575SA SU325503578SA SU323462002SA SU324342103SA SU324352110SA SU325032262SA SU325092438SA SU325092440SA SU325062324SA SU324492176SA SU324082049SA SU324322091SA SU324212077SA SU325343177SA SU324212066SA SU324212067SA SU324212069SA SU325032259SA SU324212072SA SU325072396SA SU324322092SA SU324502212SA SU324342105SA SU324082055SA SU324422119SA SU325092429SA SU325323107SA SU325333151SA SU325333153SA SU325092432SA SU325072398SA SU325092437SA SU325092439SA SU323462004SA SU325202728SA SU325503574SA SU325072395SA SU323482006SA SU323482007SA SU323482011SA SU323512015SA SU324342094SA SU324372111SA SU324502213SA SU325032264SA SU325172606SA SU325191062SA SU325202755SA SU325222774SA SU325242878SA SU325262935SA SU325323104SA SU324082051SA SU325102464SA SU324422121SA SU325092426SA SU324082057SA SU324082052SA SU324462126SA SU324212074SA SU325082403SA SU323482008SA SU324342104SA SU325072393SA
FEI Number 3012359877
Recalling Firm/
Manufacturer		 GE Medical Systems Information Technologies Inc
9900 W Innovation Dr
Milwaukee WI 53226-4856
For Additional Information ContactGE HealthCare Service
800-437-1171
Manufacturer Reason
for Recall		Electrical sparking may occur at the printer head. If the Electrostatic Discharge (ESD) printer brush becomes dislodged, electrical sparking at the printer head can result in charring or discoloration of thermal printer paper. Ignition of the paper could potentially result in serious thermal injury.
FDA Determined
Cause 2		Process control
ActionFirm notified consignees starting on April 24, 2026 via letters titled "URGENT MEDICAL DEVICE CORRECTION." Pending corrections from GE Healthcare, customers were instructed to perform a visual inspection of the printer assembly to verify proper positioning of the ESD brush. Customers may continue to use the device if the brush is properly positioned and aligned. However, if the brush appears misaligned or displaced, stop using the device and contact a GE HealthCare Service representative.
Quantity in Commerce1835
DistributionWorldwide distribution - US Nationwide and the countries of Algeria, Australia, Bangladesh, Cambodia, Canada, Croatia, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Ireland, Italy, Japan, South Korea, Lebanon, Libya, Lithuania, Malaysia, Myanmar, Netherlands, New Zealand, Norway, Philippines, Poland, Qatar, Romania, Saudi Arabia, Senegal, Singapore, South Africa, Spain, Sri Lanka, Sweden, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DQK
-
-