Events

Recall of Device Recall CIOS ALPHA

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
    73605
  • Event Risk Class
    Class 2
  • Event Number
    Z-1278-2016
  • Event Initiated Date
    2016-02-19
  • Event Date Posted
    2016-03-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144566
  • 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
    Interventional fluoroscopic x-ray system - Product Code OWB
  • Reason
    Software issues on cios alpha mobile c-arm system.
  • Action
    Siemens sent an Customer Safety Advisory Notice on February 26, 2016, to inform them of some issues that may arise on the Cios Alpha unit. The letter identified the product the problem and the action needed to be taken by the customer. Users were instructed to change the date format to DDMMYYYY to prevent issues, not to release radiation as long as the DVD icon is blinking and to disconnect and re-connect the trolley if the system is needed immediately. In the meantime they are preparing a modification of Cios Alpha that will resolve the above-mentioned issues. As soon as the modification is available, a service engineer will get in touch with each customer and implement the modification to the Cios Alpha system free of charge. If the device was sold, customers were instructed to forward the recall notification to the new owner. For further questions please call (610) 448-6478.

Device

Device Recall CIOS ALPHA
  • Model / Serial
    Model # 10308191
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to the states of : AL, AR, CA, CO, CT, DE, FL, GA, IA, IL, KY, MD, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, WA and WI
  • Product Description
    Cios Alpha, mobile X-ray system
  • 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