Events

Recall of AQUARIUS WORKSTATION - BASIC UNIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by TERARECON 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
    44611
  • Event Risk Class
    III
  • Event Initiated Date
    2014-02-04
  • 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
    Software anomaly related to the recist 1.1 target lesion evaluation criteria in the findings workflow module within the aquarius workstation intuition client viewer. in certain instances this target lesion evaluation output provided by the software may be inaccurate. the total measurement calculation and percentage of change are accurate. the affected versions are 4.4.11.82.6784 4.4.11.116.7134 and 4.4.11.144.7589.

Device

AQUARIUS WORKSTATION - BASIC UNIT
  • Model / Serial
    Model Catalog: 84-0069 (Lot serial: AQ-UH8486); Model Catalog: 84-0069 (Lot serial: AQ-UH7915); Model Catalog: 84-0069 (Lot serial: AQ-UH8040); Model Catalog: 84-0069 (Lot serial: AQ-UH4940)
  • Product Description
    AQUARIUS WORKSTATION BASIC UNIT
  • Manufacturer
    TERARECON INC.

Manufacturer

TERARECON INC.
  • Manufacturer Address
    FOSTER CITY
  • Manufacturer Parent Company (2017)
    Terarecon Inc
  • Source
    HC