Z-1070-2015Class II

Aquarius iNtuition Client Viewer. Findings Workflow module, RECIST 1.1: Picture Archiving and Communications...

Name: Z-1070-2015 Aquarius iNtuition Client Viewer. Findings Workflow module, RECIST 1.1: Picture Archiving and Communications...
Creator: TeraRecon, Inc.
Published: 2015-01-21
License: https://open.fda.gov/license/

Terarecon, Inc. / initiated 2015-01-21 / Terminated / root cause: software

FDA source

TeraRecon, Inc. began a recall of Aquarius iNtuition Client Viewer. Findings Workflow module, RECIST 1.1: Picture Archiving and Communications System; Findings Workflow Modules 4.4.11.82.6784... on 2015-01-21. FDA classified it as Class II and gives the reason as "Software anomaly related to RECIST1.1 target lesion evaluation criteria in Findings Workflow Module within the Aquarius iNtuition Client Viewer". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1070-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-21
Posted: 2015-02-09
Terminated: 2015-09-30
Recalling firm: Terarecon, Inc.
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.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Software anomaly related to RECIST1.1 target lesion evaluation criteria in Findings Workflow Module within the Aquarius iNtuition Client Viewer.
Root cause tag: software
FDA root cause: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1070-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1070-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-09

Product code LLZ

K121916Class IIIntuitionTerarecon,Inc. / cleared 2013-04-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)