🔍 RecallPedia

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.

Class I - Dangerous
🏥 Medical Devices Recalled: January 21, 2015 TeraRecon Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
TeraRecon, Inc.
Reason for Recall:
Software anomaly related to RECIST1.1 target lesion evaluation criteria in Findings Workflow Module within the Aquarius iNtuition Client Viewer.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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.

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1070-2015