Events

Recall of Device Recall Aquarius iNtuition Client Viewer

According to U.S. Food and Drug Administration, this recall involved a device in United States 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
    70426
  • Event Risk Class
    Class 2
  • Event Number
    Z-1070-2015
  • Event Initiated Date
    2015-01-21
  • Event Date Posted
    2015-02-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133581
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, image processing, radiological - Product Code LLZ
  • Reason
    Software anomaly related to recist1.1 target lesion evaluation criteria in findings workflow module within the aquarius intuition client viewer.
  • Action
    Medical Device Correction letters were sent to all affected users on January 21, 2015 by both e-mail and physical mail - certified mail for us customers and FEDEX for international customers.

Device

Device Recall Aquarius iNtuition Client Viewer
  • Model / Serial
    Serial numbers: AQ-UH6467, AQ-UH7694, AQ-UH8703, AQ-UN5993, AQ-UH8380, AQ-UH8481, AQ-UH8510, AQ-UH8511, AQ-UN5272, AQ-UH7183, AQ-UH5375, AQ-UN5266, AQ-UH6807, AQ-UH6915, AQ-UH8676, AQ-UN5143, AQ-UH8516, AQ-UN5234, AQ-UH7704, AQ-UH7705, AQ-UH7706, AQ-UH8197, AQ-UH8269, AQ-UN5247, AQ-UN5086, AQ-UN5256, AQ-UH8184, AQ-UH8454, AQ-UH8502, AQ-UH8614, AQ-UH8610, AQ-UH8609, AQ-UN5274, AQ-UN5273, AQ-UH8603, AQ-UH8597, AQ-UH8598, AQ-UN5163, AQ-UH3663, AQ-UH8309, AQ-UN5268, AQ-UN5269, AQ-UH8574, AQ-UH8575, AQ-UH8576, AQ-UH8365, AQ-UN5250, AQ-UH7862, AQ-UH7863, AQ-UH7864, AQ-UH8617, AQ-UH8551, AQ-UH8565, AQ-UH8586, AQ-UH8585, AQ-UN5267, AQ-UH8541, AQ-UN5261, AQ-UH8294, AQ-UN5260, AQ-UH8367, AQ-UH8684, AQ-UH2305, AQ-UH8489, AQ-UH5116, AQ-UN5275, AQ-UH8618, AQ-UH8054, AQ-UH7915, AQ-UH8040, AQ-UH4940, AQ-UH8486, AQ-UH8320, AQ-UH8321,AQ-UN5253, AQ-UH7156, AQ-UH7844, AQ-UH8666, AQ-UH7848, AQ-UN5115, AQ-UH8351, AQ-UH8352, AQ-UH8353, AQ-UH8354, AQ-UH8355, AQ-UH8214, AQ-UH7874, AQ-UH3098, AQ-UH8102, AQ-UN5113, AQ-UH8100
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-US (nationwide) and the countries of Canada, Switzerland, Germany, France and Italy.
  • Product Description
    Aquarius iNtuition Client Viewer. Findings Workflow module, RECIST 1.1: || Picture Archiving and Communications System; || Findings Workflow Modules 4.4.11.82.6784, 4.4.11.116.7134, 4.4.11.144.7589. || A fully-configured iNtuition system is capable of various image processing and || visualization functions, including basic features and advanced post processing || modules. The system can be configured as a server with some, all, or none of its || optional features disabled. || The intended use of the device is to provide solutions to various medical || image-analysis and viewing problems, which come about as modalities generate more and more images. It also supports image distribution over networks, and is DICOM compliant.
  • Manufacturer
    TeraRecon, Inc.

Manufacturer

TeraRecon, Inc.
  • Manufacturer Address
    TeraRecon, Inc., 4000 E 3rd Ave Ste 200, Foster City CA 94404-4805
  • Manufacturer Parent Company (2017)
    Terarecon Inc
  • Source
    USFDA