Events

Recall of ARTIS ZEE CEILING

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
    32427
  • Event Risk Class
    II
  • Event Initiated Date
    2012-10-02
  • 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
    A particular component may not have been fitted correctly during the installation of some mavig portegra 2 systems (a ceiling suspension system). the component in question is not actively involved in the operation of the mavig portegra 2 system and its absense does not have an adverse effect on system function. the component would hold a pin in position in case that pin gets released and thus prevent system parts from becoming loose leading to an adverse effect on the function and possibly becoming detached from the system.

Device

ARTIS ZEE CEILING
  • Model / Serial
    Model Catalog: 10094137 (Lot serial: ); Model Catalog: 7727717 (Lot serial: ); Model Catalog: 10094139 (Lot serial: ); Model Catalog: 7555365 (Lot serial: ); Model Catalog: 10094135 (Lot serial: ); Model Catalog: 7412807 (Lot serial: ); Model Catalog: 7728392 (Lot serial: ); Model Catalog: 7008605 (Lot serial: ); Model Catalog: 10280959 (Lot serial: ); Model Catalog: 59 17 054 (Lot serial: ); Model Catalog: 10094141 (Lot serial: ); Model Catalog: 7555357 (Lot serial: ALL SERIAL NUMBERS)
  • Product Description
    ARTIS ZEE CEILING
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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