Events

Recall of Axiom Artis dMP

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
    53844
  • Event Risk Class
    Class 2
  • Event Number
    Z-0484-2010
  • Event Initiated Date
    2009-10-26
  • Event Date Posted
    2009-12-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-01-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86658
  • 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
    Angiographic x-ray system - Product Code IZI
  • Reason
    C-arm may tilt.
  • Action
    The firm has issued a Customer Safety Advisory Notice via Update Instructions AX051/09/S to affected customers. This letter informs customers of the potential malfunction and of the possible danger to patients, users or other persons.

Device

Axiom Artis dMP
  • Model / Serial
    Serial numbers: 57004, 57008, 57009, 57012, 57016, 57024, 57041, 57045, 57054, 57072, 57073, 57076, 57077, 57089, 57098, 57105, 57111, 57116, 57117, 57124, 57144, 57155, 57156, 57171, 57183, 57187, 57188, 57189, 57193, 57198, 57201, and 57204.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Axiom Artis dMP, Model number 7555365 || angiographic x-ray systems
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA