Events

Recall of Device Recall Artis zee biplane

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-3092-2017
  • 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=158184
  • 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 biplane
  • Model / Serial
    Artis zee biplane- Serial number: 154502 154616 154536 154096 154454 154715 154789 154779 154532 131017 154157 154722 154721 154571 154074 154612 154090 154658 154686 154095 154567 154480 154093 154086 154704 153882 154727 154408 154509 154079 154462 154098 154073 154076 154792 154156 154799 154814 154783 154731 154683 153878 154565 154653 154671 154556 154406 154518 154778 154685 137650 131005 154633 154020 154058 154155 153884 154453 154708 154579 154762 154034 154018 154560 154596 154066 154663 154544 154614 154048 154800 154592 154684 154087 154085 154471 154606 154604 154456 154687 154707 154459 131000 154581 154423 154546 154052 154028 154084 154732 154709 154678 131011 154430 154501 154514 154075 154064 154562 154585 154044 154770 154035 154056 154785 154425 154082 154429 154055 154631 154476 154088 154067 154584 154610 154094 154576 154089 154041 154739 154077 154602 154097 154615 154572 154564
  • 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