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
    36689
  • Event Risk Class
    III
  • Event Initiated Date
    2016-05-24
  • 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
    During manufacturing process it was discovered that the crimp-connection of a cable was faulty. in case the cable gets loose the high voltage circuit of the system is discharging extremely slow after powering off the system.This error may not lead to any harm to patients or users. the risk remains only to service personnel and only if they do not follow the described procedures for servicing the high voltage circuits in the device.

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