Events

Recall of PENTACAM AXL

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by OCULUS OPTIKGERAETE GMBH.

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
    133626
  • Event Risk Class
    II
  • Event Initiated Date
    2017-11-28
  • 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
    Possibility of displaying the erronous output when a specific workflow sequence for performing the power calculation is utilized. the colored display of the quality specifications (qs) value changes from yellow to white while the output values remained the same.

Device

PENTACAM AXL
  • Model / Serial
    Model Catalog: 70100 (Lot serial: 1.21r11); Model Catalog: 70100 (Lot serial: Software versions:); Model Catalog: 70100 (Lot serial: 1.21r13); Model Catalog: 70100 (Lot serial: 1.21r03); Model Catalog: 70100 (Lot serial: 1.21r01)
  • Product Description
    PENTACAM AXL
  • Manufacturer
    OCULUS OPTIKGERAETE GMBH

Manufacturer

OCULUS OPTIKGERAETE GMBH
  • Manufacturer Address
    WETZLAR
  • Source
    HC