Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Aquarius iNtuition Client Viewer

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Aquarius iNtuition Client Viewer see related information
Date Initiated by Firm January 21, 2015
Date Posted February 09, 2015
Recall Status1 Terminated 3 on September 30, 2015
Recall Number Z-1070-2015
Recall Event ID 70426
510(K)Number K121916  
Product Classification System, image processing, radiological - Product Code LLZ
Product 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.
Code Information 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 
Recalling Firm/
Manufacturer		 TeraRecon, Inc.
4000 E 3rd Ave Ste 200
Foster City CA 94404-4805
For Additional Information Contact Emilly Nurthen
650-372-1100 Ext. 282
Manufacturer Reason
for Recall		 Software anomaly related to RECIST1.1 target lesion evaluation criteria in Findings Workflow Module within the Aquarius iNtuition Client Viewer.
FDA Determined
Cause 2		 Software design
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.
Quantity in Commerce 91
Distribution Worldwide Distribution-US (nationwide) and the countries of Canada, Switzerland, Germany, France and Italy.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = TERARECON, INC.
-
-