Events

Recall of CIOS ALPHA

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SIEMENS HEALTHCARE LIMITED.

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
    147593
  • Event Risk Class
    II
  • Event Initiated Date
    2015-05-05
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    The following user actions may cause the system to freeze and the system may become temporarily inoperable: -when images were transferred from the left monitor to the right monitor (function a to b) during image acquisition (i.E. radiation on) or shortly before starting image acquisition. - when acquisition of image was started while storing of scenes initiated by pressing the store button was still in progress. - when scene replay was initiated either automatically or by pressing the "play" button (especially when pressing the "play" button more than once) while the storing of those scenes was still in progress. - when image acquisition was initiated again before automatic replay of the last scene started. - when finalized cd/dvds were used to store additional data. - when radiation summary reports with more than 190 entries were being exported. - when system restart was initiated when the error message "system blocked. turn system off/on" (error codes 215/80 and/or 208/80) was displayed. if a system freeze occurs a system reset is required to resume fully operation. this process may take approximately 4 minutes. during the reset process no x-ray imaging is available at cios alpha mobile c-arm x-ray system.

Device

CIOS ALPHA
  • Model / Serial
    Model Catalog: 10308191 (Lot serial: 10071)
  • Product Description
    CIOS ALPHA
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Manufacturer Address
    OAKVILLE
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    HC