Events

Recall of Device Recall DatexOhmeda S/5 Compact Critical Care Monitor

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

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
    51278
  • Event Risk Class
    Class 2
  • Event Number
    Z-1995-2009
  • Event Initiated Date
    2006-02-06
  • Event Date Posted
    2009-09-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83640
  • 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
    Monitor, st segment with alarm - Product Code MLD
  • Reason
    Ge healthcare (datex-ohmeda) s/5 critical care monitor and s/5 compact critical care monitor with l-cicu01, l-cicu02a, l-icu05 & l-icuo5a software had an issue where the heart rate (hr) was displaying as ---(3 dashes) when the monitor was used continuously for 49 days without a cold start. a missed alarm or missed hr value could cause a delay in recognition of a cardiac event that may result i.
  • Action
    GE Healthcare Technologies issued a Marketing Bulletin "Ref: MB MS HKI 06007" dated February 6, 2006 to explain a software update.

Device

Device Recall DatexOhmeda S/5 Compact Critical Care Monitor
  • Model / Serial
    Serial Numbers: 5128889 5128890 5128891 5128892 5128893 5128894 5128895 5128896 5128897 5128898 5128899 5128900 5128901 5128902 5128903 5128904 5128905 5128906 5128907 4477168 4664492 4664501 4664502 4664503 4664504 4895486 4941851 4933633 4933634 4933635 5123856 5123857 5123858 5123859 5123860 6091772 6091793 6091798 6091808 6091810 6091812 6091815 4677835 4686814 4686815 4801836 4933640 4933641 4501834 4501835 4677816 4851329 4851330 4851331 4851332 4851333 4851334 4851335 4851336 4479683 4895480 4895481 4895482 4895483 5148283 5148284 5148285 5148286 5148287 4477184 4477185 4477186 4477187 4477188 4477189 4477190 4477191 4477192 4477193 4477194 4477195 4477196 4477198 4477199 4477200 4477201 4477972 485135 4290001 4695833 4695834 4695835 4695836 4851358 4851359 4851360 4933632 5186416 5186417 5186418 5128888 5195464 6063039 6063073 6063074 6063075 6063078 6063170 6063171 6063172 6063173 6063176 6063177 6063178 6063104 6063107 6091814 6098549 6091788 6033273 6029184 6033292 6034325 6071339 6098570 6098572 6098635 6098636 6080649 6080652 6024822 6080714 6080726 6080737 6086854 6086857 6086862 6091801 6091806 6108988 6026830 6026832 6080728 6080731 6080733 6080743 6080748 6080756 6080762 6009191 6108972 6108975 6063072 6086922 6086933 6091754 6091697 6091699 6091705 6091713 6091714 6108949 6108980 6108981 6032063 6034393 6034394 6034408 6080648 6080651 6087043 6087044 6087046 6087047 6091693 6091824 6098543 6098551 6098683 6098684 6108924 6056086 5218184 6017219 6071349 6080736 6080750 6108991 6071424 6086924 6086926 6086927 6086935 6086948 6098658 6003166 6009180 6009181 6009182 6009183 6009184 6009185 6009186 6009187 6009188 6009189 6009192 6009193 6013447 6013450 6013451 6013453 6013454 6013458 6013459 6015390 6015393 6015394 6015395 6028333 6028341 6028346 6032084 6032086 6032087 6032088 6032090 6032093 6032094 6032096 6032097 6032098 6032099 6032101 6032102 6032104 6032091 6034356 6041888 6041899 6041901 6041919 6041921 6041930 6047589 6047590 6047591 6071351 6071353 6071355 6071358 6098672 6098682 6098690 6108923 6108926 6108950 6108953 6108965 6017274 6026822 6028316 6032069 6032112 6032116 6032118 6033246 6034335 6034337 6034340 6034341 6034342 6034346 6034347 6034359 6056043 6056047 6056048 6056051 6063053 6086881 6086898 6086900 6086902 6086919 6091741 6108968 6108969 6108970 6108973 6017276 6017278 6024825 5224920 6056097 6063046 6063047 6063050 6063051 6063052 6063055 6063056 6063065 6063100 6063179 6071365 6071366 6071368 6071370 6071371 6071373 6071374 6071375 6071376 6071377 6071378 6071379 6071380 6071381 6071383 6071384 6071385 6071387 6071389 6071391 6071392 6071393 6071394 6071395 6071401 6071402 6071404 6071406 6071407 6071408 6071413 6071429 6076860 6076861 6076863 6033255 6041868 6041895 6041915 6041917 6098562 6098563 6098564 6098568 6098571 6098585 6098586 6098589 6098591 6098594 6098602 6098606 6098624 6098625 6098626 6098627 6098628 6098629 6098631 6098632 6098633 6098653 6098656 6098662 6098664 6029194 6029195 6029207 6029209 6091773 6091785 6091786 6091787 6091789 6091790 6091792 6091794 6091795 6091796 6091799 6091802 6091804 6091805 6091807 6091816 6091817 6091818 6091819 6091820 6091821 6091822 6091828 6098552 6098553 6063092 6098565 6098581 6098582 6098584 6098588 6098590 6098592 6098593 6098597 6098600 6098603 6098604 6091777 6063081 6063084 6063101 6063102 6063103 6080751 6080766 6080770 6091734 6091740 6091742 6091748 6091770 6098691 6108982 6108992 6034355 6080637 6080639 6080664 6080666 6080673 6080675 6091726 6091728 6091730 6091737 6091743 6091744 6091745 6091746 6091747 6056117 6063066 6063114 6086904 6086906 6108947 6108948 5211153 6034403 6086973 6087001 6087026 6087033 6087040 6032076 6071433 6091765 6091780 6091784 6098673 6032075 6032077 6063111 6071316 6071326 6071327 6071328 6071329 6071332 6071333 6071334 6071335 6071336 6071337 6071341 6071343 6071434 6071435 6071436 6071437 6071438 6098670 6098671 6098675 6098677 6098678 6098679 6086938 6086974 6086975 6086976 6086978 6086994 6047570 6056110 6056116 6063049 6063174 6086941 6091685 6091722 and 6091729.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    ITALY, AUSTRALIA, AUSTRIA, BELGIUM, BOLIVIA, BRASIL, BULGARIA, CHILE, CHINA, COLOMBIA, COSTA RICA, CYPRUS, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, IRAN, ISRAEL JORDAN, LITHUANIA, ITALY, MACEDONIA, MALAYSIA, MEXICO, NETHERLAND, NICARAGUA, NORWAY, POLAND, PORTUGAL PUERTO RICO, RUSSIA, SINGAPORE, SLOVAK IA, SOUTH AFRICA, SPAIN, SWEDEN, SYRIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA.
  • Product Description
    Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A software. || CCCM || Indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinavregional perfusion, B ispectral index (BIS), and neurophysiological status of all hospital patients.
  • Manufacturer
    GE Medical Systems Information Tecnology

Manufacturer

GE Medical Systems Information Tecnology
  • Manufacturer Address
    GE Medical Systems Information Tecnology, 9900 Inovation Drive, RP 2122 3rd Floor, Wauwatosa WI 53226
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA