Events

Recall of Device Recall Artis zee ceiling

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions USA, Inc.

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
    77908
  • Event Risk Class
    Class 2
  • Event Number
    Z-3094-2017
  • Event Initiated Date
    2016-02-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-11-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158186
  • 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
    System, x-ray, angiographic - Product Code IZI
  • Reason
    Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. loss of coolant can results in a cooling system failure and subsequent system failure. this leek can occur sporadically in affected systems.
  • Action
    Siemens mailed a Customer Safety Advisory Notice (CSAN) dated February 18, 2016, to affected customers informing them that their service organization will contact them to arrange a date to perform the corrective action (replacement of affected plastic couplings to prevent fluid leaks). Customers were advised to contact Siemens service organization for an appointment to schedule the work For questions regarding this recall call 610-.448-6461.

Device

Device Recall Artis zee ceiling
  • Model / Serial
    Artis zee ceiling - Serial number: 146996 147100 147233 147049 147678 147763 147803 147885 147084 147190 147189 147573 147889 146993 147909 147833 147847 147888 146965 147273 147761 147030 147239 147783 147891 146988 147677 147882 147562 147608 146980 147036 147581 147857 125001 147604 147371 147899 147129 147210 147923 147760 147636 147081 147267 147047 147679 147667 125002 147685 125011 147042 147630 147835 147208 147247 147096 147912 147515 147236 147175 146972 147841 147078 147924 147023 147910 147934 147921 147919 147255 147249 147514 147954 147918 147165 147188 147926 147928 147925 147558 146968 147956 147958 147957 147955 147304 147944 147024 147724 125005 147172 147585 147553 147736 147645 147906 147164 147974 147087 147972 146856 146921 147938 125006 147193 147196 147025 147583 147852 147044 147814 147203 147601 147659 147894 147675 147098 147905 147113 147516 147107 147700 147167 147702 147935 147500 147121 147969 147745 147898 147936 147106 147850 147681 147795 147845 146855 146957 147652 147773 147243 125010 147827 147789 147878 147877 147541 147831 147124 147119 147120 147144 147237 147240 147709 147577 147896 147268 147168 147029 125004 147587 147285 147612 147880 147526 147625 147635 146987 146983 146975 147296 147171 147695 146971 146969 146973 147200 147733 147059 147177 147238 147692 147693 147753 147241 147089 146919 147821 147009 147648 147114 147216 147866 147214 146963 147373 147123 147762 147174 147668 147083 147755 147673 147887 147800 146964 147816 147815 147561 147155 147939 147771 147665 147657 146991 146857 147867 147871 147813 147088 147660 147649 147093 147264 147364 125003 147075 147775 147790 125000 147781 147839 147862 147655 147734 147900 147079 147643 147748 146960 147027 147559 147620 146982 147715 147287 147507 147838 147749 147633 147881 147737 147621 147205 147250 147254 147253 147252 147251 125008 147893 147676 147717 147778 147952 147931 147933 146929 146925 147927 147799 147365 147157 147892 147662 146927 147207 147646 147670 147234 147552 147295 147046 147644 147701 147666 147557 147661 147307 147766 147971 147718 147917 147103 147303 147849 147842 147265 147301 147235 147094 147716 147739 147743 147752 147937 147031 147746 147528 147656 147940 146977 147687 147109 147863 147186
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic || AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients. Procedures that can be performed with the AXIOM Artis-zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 40 Liberty Blvd, Malvern PA 19355-1418
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA