Events

Recall of Device Recall Artis zee/zeego system, xray, angiographic

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
    73548
  • Event Risk Class
    Class 2
  • Event Number
    Z-1299-2016
  • Event Initiated Date
    2016-02-26
  • Event Date Posted
    2016-03-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144445
  • 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
    In artis zeego systems, angulations in the vicinity of the c-arm collision area can cause the cable inlet to become clamped and can result in mechanical damage. in artis systems with a100plus generators, an attempt to resume operation following detection of a fault (such as a short circuit in the x-ray tube) can result in the failure of a module in the high-voltage generator.
  • Action
    The firm, Siemens, sent an "Important Customer Safety Notice" dated 2/16/2016 to its customers. The notice informed them of a corrective action that will be performed to prevent a possible hazard to patients, operators, other persons or equipment. The notice described the product, problem and actions to be taken. Siemens plans to contact each customer to arrange a date to add additional protection mechanisms by means of a system software update. If you have any questions, contact Engineer, Regulatory Technical Specialist at 610-448-6461 or email: Meredith.adams@siemens.com.

Device

Device Recall Artis zee/zeego system, xray, angiographic
  • Model / Serial
    Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution including states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, GU, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and PUERTO RICO.
  • Product Description
    system, x-ray, angiographic, model # 10094135, 10094137, 10094139, 10094141, 10280959 || Artis zee/ zeego 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.
  • 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