Events

Recall of Device Recall Axiom Artis U

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
    59275
  • Event Risk Class
    Class 2
  • Event Number
    Z-3009-2011
  • Event Initiated Date
    2011-06-29
  • Event Date Posted
    2011-08-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102094
  • 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, mobile - Product Code IZL
  • Reason
    When the heat unit of the angiography system reaches or exceeds 65%, the cool down time display will appear with an acoustic signal. if users ignore the warning and continue the radiation, the tube may be autoprotected when it reaches its temperature limitation causing the x-ray to lock until the tube cools down. following a tube auto-protection, an error message "door is open" or "err 421/240:.
  • Action
    Siemens sent a "Customer Safety Advisory Notice" letters to all affected users dated June 13, 2011. The letter identified the product, the problem, and the actions to be taken. Siemens included in the notice an addendum to the instruction for use to each system and request customers to take special attention. Customers were instructed to place the Safety Notice in the System's instruction for use. All appropriate personnel should be notified of the correction notice. If product was distributed further, customers were to forward the safety notice to the new owner and inform the firm of the new owner.

Device

Device Recall Axiom Artis U
  • Model / Serial
    Model number 10094012; serial numbers 20202, 20223, 20231, 20422, 20402, 20435, 21022, 22002, 21005, and 20432.   Model number 7008530; serial numbers 20146, 21112, 20003, 20115, 20135, 20006, 20113, and 20120.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution (USA) including the states of: CA, CT, FL, KS, MN, MO, NJ, NY, NC, PA, and UT.
  • Product Description
    Siemens Axiom Artis U mobile x-ray system || Product Usage: Mobile x-ray system
  • 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