Events

Recall of Artis zee/ zeego systems

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
    69478
  • Event Risk Class
    Class 2
  • Event Number
    Z-0854-2015
  • Event Initiated Date
    2014-09-17
  • Event Date Posted
    2015-01-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130745
  • 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
    The small focus of a 3 focal spot x-ray tube may fail and further release of radiation will not be possible. the large focus and micro focus focal spots will still be operational without any restriction. manual switchover is needed, resulting in a short interruption of the procedure.
  • Action
    Planned action (s) to repair defect or to bring product into compliance for Siemens Medical Solutions Inc. concerning the corrective action plan (CAP) for the Model(s) Artis Zee/Zeego Stationary Angiographic X-ray Systems. 1.Notifying the customer of the defect. 2.Implementing a corrective software patch to protect the system from damage in the event of hardware failure 3. Scheduling a service visit from a Siemens representative to perform a hardware replacement. 4. Replacing the non-conforming X-ray tube with one manufactured after the nonconformity issue was resolved. For further questions please call (610) 219-6300.

Device

Artis zee/ zeego systems
  • Model / Serial
    model numbers: 10094135, 10094137, 10094139, 10094141, 10280959, with serial numbers: 160348 146643 147129 146630 147208 146972 153707 147378 146742 157650 146986 147098 157696 153946 146940 147144 147029 160384 153884 147009 153628 153706 146729 147155 153790 146896 153757 136503 147372 136345 153762 146883 160421 153195 146427 153834 135927 154157 135862 153998 153257 153220 153682 160341
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA Distribution to the states of MO, MI, NY, OK, CA, LA, CT, IN, VA, MD, WA, HI, ME, TX, NY, OH, PA and CO.
  • Product Description
    Artis zee/ zeego systems, model numbers: 10094135, 10094137, 10094139, 10094141, 10280959: 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 include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 40 Liberty Blvd, Mail Code: 65-1A, Malvern PA 19355-1418
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA