Events

Recall of Device Recall MAC 800 RESTING ECG ANALYSIS SYSTEM

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Medical Systems, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    53164
  • Event Risk Class
    Class 2
  • Event Number
    Z-0645-2010
  • Event Initiated Date
    2009-12-10
  • Event Date Posted
    2010-01-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84831
  • Notes / Alerts
    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.
  • Extra notes in the data
    Electrocardiograph - Product Code DPS
  • Reason
    Ge healthcare has become aware of an issue with mac800 laser printouts. when more than one ecg report in the file manager is batch printed in laser print, the potential exists for an incorrect patient identification or name to be displayed on the print out. misidentification of patient data potentially contributing to delayed or incorrect treatment is then possible.
  • Action
    Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated December 10, 2009. The letter was addressed to Healthcare Administrator/Risk Manager, Chief of Nursing and Director of Biomedical Engineering. The letter described the Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. GE Healthcare will provide a software upgrade to resolve the issue. A GE Healthcare representative will contact customers to schedule implementation of the correction when it is available for installation at the customer facility. Direct questions to the GE Healthcare Technologies Support Center at 1-800-558-7044, enter Option 2 and ask for Technical Support or your local GE Field Service Representative.

Device

Device Recall MAC 800 RESTING ECG ANALYSIS SYSTEM
  • Model / Serial
    Serial number / Lot name of the target item: SDS08350002SA SDS08350003SA SDS08350008SA SDS08350017SA SDS08350018SA SDS08360012SA SDS08360014SA SDS08360015SA SDS08360016SA SDS09060040SA SDS09070065SA SDS09090075SA SDS09090076SA SDS09090077SA SDS09090078SA SDS09090079SA SDS09090080SA SDS09090082SA SDS09090083SA SDS09090084SA SDS09090085SA SDS09090086SA SDS09090087SA SDS08340005WA SDS08340021WA SDS08340008WA SDS08340011WA SDS08340018WA SDS08500136WA SDS08500137WA SDS08500138WA SDS08500139WA SDS08500140WA SDS08500141WA SDS09020164WA SDS09020165WA SDS09020166WA SDS09020167WA SDS09020181WA SDS09030199WA SDS09030210WA SDS09030215WA SDS09030218WA SDS09030219WA SDS09070223WA SDS09120318WA SDS08340014WA SDS09030183WA SDS09030185WA SDS09030186WA SDS09030191WA SDS09030192WA SDS09090297WA SDS09100298WA SDS09100299WA SDS09230533WA SDS08480129WA SDS09030200WA SDS09030207WA SDS09030211WA SDS09030212WA SDS09030214WA SDS09070220WA SDS09120319WA SDS09120320WA SDS09120321WA SDS09120327WA SDS09120330WA SDS09140336WA SDS09140337WA SDS09200449WA SDS09230531WA SDS09230538WA SDS08340013WA SDS09190434WA SDS09200444WA SDS09200450WA SDS09040023SA SDS09140333WA SDS08430032WA SDS09140350WA SDS09160386WA SDS09210471WA SDS09210472WA SDS09220497WA SDS09220501WA SDS09220502WA SDS09220503WA SDS09220504WA SDS09220506WA SDS09220507WA SDS09220508WA SDS08340019WA SDS09220509WA SDS09220512WA SDS08480127WA SDS09200446WA SDS09200447WA SDS09200448WA SDS09220511WA SDS09220513WA SDS09220514WA SDS09220515WA SDS09220516WA SDS09220517WA SDS09220518WA SDS09140335WA SDS08450062WA SDS09120331WA SDS08340015WA SDS09200452WA SDS09230520WA SDS09230521WA SDS09230522WA SDS08340007WA SDS09070221WA SDS09070226WA SDS09140338WA SDS09140339WA SDS09140340WA SDS09140341WA SDS09140342WA SDS09140343WA SDS09140344WA SDS09140345WA SDS09140346WA SDS09140347WA SDS09140348WA SDS09140349WA SDS09140351WA SDS09140352WA SDS09150353WA SDS09150354WA SDS09150355WA SDS09150356WA SDS09150357WA SDS09150358WA SDS09150359WA SDS09150360WA SDS09150361WA SDS09150362WA SDS09150363WA SDS09150364WA SDS09150365WA SDS09150366WA SDS09150367WA SDS09150368WA SDS09150369WA SDS09150370WA SDS09150371WA SDS09150372WA SDS09160378WA SDS09160379WA SDS09160380WA SDS09160381WA SDS09160382WA SDS09160383WA SDS09160384WA SDS09160385WA SDS09160387WA SDS09160388WA SDS09160389WA SDS09160390WA SDS09160391WA SDS09160392WA SDS09160393WA SDS09160394WA SDS09160395WA SDS09160396WA SDS09160397WA SDS09160398WA SDS09160399WA SDS09160400WA SDS09160401WA SDS09160402WA SDS09160403WA SDS09160404WA SDS09160405WA SDS09160406WA SDS09160407WA SDS09160408WA SDS09160409WA SDS09160410WA SDS09160411WA SDS09160412WA SDS09220473WA SDS09220474WA SDS09220475WA SDS09220476WA SDS09220477WA SDS09220478WA SDS09220479WA SDS09220480WA SDS09220482WA SDS09220483WA SDS09220484WA SDS09220485WA SDS09220486WA SDS09220487WA SDS09220488WA SDS09220489WA SDS09220490WA SDS09220491WA SDS09220492WA SDS09220493WA SDS09220494WA SDS09220495WA SDS09220496WA SDS09220498WA SDS09220499WA SDS09220500WA SDS09220505WA SDS08470118WA SDS08470121WA SDS08470123WA SDS08470124WA SDS08480130WA SDS08480131WA SDS08480132WA SDS08500133WA SDS08500134WA SDS08500135WA SDS08500142WA SDS08500143WA SDS08500144WA SDS08500145WA SDS08500146WA SDS08500147WA SDS08500148WA SDS08500149WA SDS08500150WA SDS08500151WA SDS08500152WA SDS08500153WA SDS08500154WA SDS08500155WA SDS08500156WA SDS08500157WA SDS09020169WA SDS09020174WA SDS09020180WA SDS09030195WA SDS09030198WA SDS09030204WA SDS09030216WA SDS09030217WA SDS09040022SA SDS09040024SA SDS09040025SA SDS09040026SA SDS09070224WA SDS09120322WA SDS09120323WA SDS09120324WA SDS09120325WA SDS09120326WA SDS09120328WA SDS09120329WA SDS09230524WA SDS09230525WA SDS09230529WA SDS09230530WA SDS09030201WA SDS09030197WA SDS09080249WA SDS09080254WA SDS09080255WA SDS08340020WA SDS09030187WA SDS09030190WA SDS09200453WA SDS09200454WA SDS09200455WA SDS09200456WA SDS09200457WA SDS09200458WA SDS09200459WA SDS09200460WA SDS09200461WA SDS09200462WA SDS09210463WA SDS09210464WA SDS09210465WA SDS09210466WA SDS09210467WA SDS09210468WA SDS09210469WA SDS09210470WA SDS09160374WA SDS09120332WA SDS09230526WA SDS08470119WA SDS08470120WA SDS08470122WA SDS08480126WA SDS08500158WA SDS08500159WA SDS08500161WA SDS08500162WA SDS09020163WA SDS09020170WA SDS09020171WA SDS09020172WA SDS09020173WA SDS09020175WA SDS09020176WA SDS09020177WA SDS09020182WA SDS09030184WA SDS09030188WA SDS09030193WA SDS09030213WA SDS09230527WA SDS09230534WA SDS09230535WA SDS09230536WA SDS09230539WA SDS08340009WA SDS08340010WA SDS08340025WA SDS08340026WA SDS08480125WA SDS08430034WA SDS08430035WA SDS08430036WA SDS08340022WA SDS08340023WA SDS08340024WA SDS08340027WA SDS08480128WA SDS09030196WA SDS09030202WA SDS09030203WA SDS09030205WA SDS09030208WA SDS09030209WA SDS09070222WA SDS09070225WA SDS09220510WA SDS08340012WA SDS09140334WA SDS09020168WA SDS08430033WA SDS08430037WA SDS08430038WA SDS08430039WA SDS08440040WA SDS08440041WA SDS08440042WA SDS08440043WA SDS08440044WA SDS08440045WA SDS08440046WA SDS08440047WA SDS08440048WA SDS08440049WA SDS08440050WA SDS08440051WA SDS08440052WA SDS08440053WA SDS08440054WA SDS08440055WA SDS08440056WA SDS08440057WA SDS08440058WA SDS08440059WA SDS08440060WA SDS08440061WA SDS08450063WA SDS08450064WA SDS08450065WA SDS08450066WA SDS08450067WA SDS08450068WA SDS08450069WA SDS08450070WA SDS08450071WA SDS08450073WA SDS08450074WA SDS08450075WA SDS08460076WA SDS08460077WA SDS08460078WA SDS08460079WA SDS08460080WA SDS08460081WA SDS08460082WA SDS08460083WA SDS08460084WA SDS08460085WA SDS08460086WA SDS08460087WA SDS08460088WA SDS08460089WA SDS08460090WA SDS08460091WA SDS08460092WA SDS08470093WA SDS08470094WA SDS08470095WA SDS08470096WA SDS08470097WA SDS08470098WA SDS08470099WA SDS08470114WA SDS08470115WA SDS09020178WA SDS09070241WA SDS09070242WA SDS09080256WA SDS09080257WA SDS09080258WA SDS09080259WA SDS09080260WA SDS09080261WA SDS09080262WA SDS09080263WA SDS09080264WA SDS09080265WA SDS09080266WA SDS09080267WA SDS09080268WA SDS09080269WA SDS09080270WA SDS09080271WA SDS09080272WA SDS09090273WA SDS09090275WA SDS09090276WA SDS09090278WA SDS09090279WA SDS09090280WA SDS09090281WA SDS09090282WA SDS09090296WA SDS09110312WA SDS09110317WA SDS09180415WA SDS09180416WA SDS09180417WA SDS09180425WA SDS09180429WA SDS09180430WA SDS09240568WA SDS09240569WA SDS09240570WA SDS09240571WA SDS09240572WA SDS09240573WA SDS09240574WA SDS09180423WA SDS09180424WA SDS08470116WA SDS08470117WA SDS09160373WA SDS08470100WA SDS08470101WA SDS08470102WA SDS08470103WA SDS08470104WA SDS08470105WA SDS08470106WA SDS08470107WA SDS08470108WA SDS08470109WA SDS08470110WA SDS08470111WA SDS08470112WA SDS08470113WA SDS09020179WA SDS09070228WA SDS09070229WA SDS09070230WA SDS09070233WA SDS09070234WA SDS09070235WA SDS09070237WA SDS09070238WA SDS09070239WA SDS09070240WA SDS09070243WA SDS09070244WA SDS09070245WA SDS09070246WA SDS09070247WA SDS09080248WA SDS09080250WA SDS09080251WA SDS09080252WA SDS09080253WA SDS09070231WA SDS09070232WA SDS09090274WA SDS09090277WA SDS09090283WA SDS09090284WA SDS09090285WA SDS09090286WA SDS09090287WA SDS09160375WA SDS09160376WA SDS09160377WA SDS09180413WA SDS09180414WA SDS09180418WA SDS09180419WA SDS09180420WA SDS09180421WA SDS09180422WA SDS09180426WA SDS09180427WA SDS09180428WA SDS09190435WA SDS09190436WA SDS09190437WA SDS09200438WA SDS09200439WA SDS09200440WA SDS09200441WA SDS09200442WA SDS09200443WA SDS09200451WA SDS09230546WA SDS09230547WA SDS09240575WA SDS09240576WA SDS09240577WA SDS09250587WA SDS08340003WA SDS08340004WA SDS08340006WA SDS09090288WA SDS09090289WA SDS09090290WA SDS09090291WA SDS09090292WA SDS09090293WA SDS09090294WA SDS09090295WA SDS09100300WA SDS09100301WA SDS09100302WA SDS09100303WA SDS08450072WA SDS09100304WA SDS09100305WA SDS09100306WA SDS09100307WA SDS09110308WA SDS09110309WA SDS09110310WA SDS09110311WA SDS09110313WA SDS09110314WA SDS09180431WA SDS09180432WA SDS09190433WA SDS08340016WA SDS08340017WA SDS09230548WA SDS09230549WA SDS09230550WA SDS09030194WA SDS08500160WA SDS09030206WA SDS09200445WA and SDS09070227WA.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States (CA, CO, CT, FL, IL,MD, NY, NC, OH, TN, TX, WA and WI), UNITED KINGDOM, UNITED ARAB EMIRATES, THAILAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVAKIA, SINGAPORE, ROMANIA, QATAR, PORTUGAL NETHERLANDS, LITHUANIA, KOREA, JAPAN, ITALY, ISRAEL, INDIA, HUNGARY, HONG KONG, GREECE, GERMANY, FRANCE, CZECH REPUBLIC, CROATIA, CHINA, BAHRAIN, AUSTRIA and AUSTRALIA.
  • Product Description
    GE Healthcare MAC 800 RESTING ECG ANALYSIS SYSTEM. || The MAC 800 is a portable EGG acquisition, analysis and recording system. The MAC 800 is intended to acquire, analyze, display and record information from adult and pediatric populations. Pediatric population is defined as patients between the ages of 0 and 15 years. The MAC 800 is intended to be || used by trained operators in a hospital or medical professional's facility environment to record EGG signals from surface electrodes. The basic system shall provide 2 modes of operation: (I) Resting EGG mode and (2) Arrhythmia mode. The basic systems shall print 3, 6-leads of EGG. The device shall be upgradeable to provide software options such as 12-lead ECG measurement and interpretive analysis.
  • Manufacturer
    GE Medical Systems, LLC

Manufacturer

GE Medical Systems, LLC
  • Manufacturer Address
    GE Medical Systems, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA