Z-2166-2011

DigiView software release 3.4.4.4 through 3.5.5.2. , 2008 Digisonics, Inc, 800-940-3240. Digiview is a...

Name: Z-2166-2011 DigiView software release 3.4.4.4 through 3.5.5.2. , 2008 Digisonics, Inc, 800-940-3240. Digiview is a...
Creator: Digisonics, Inc
Published: 2008-11-04
License: https://open.fda.gov/license/

Digisonics, Inc / initiated 2008-11-04 / Terminated / root cause: design

FDA source

Digisonics, Inc began a recall of DigiView software release 3.4.4.4 through 3.5.5.2. , 2008 Digisonics, Inc, 800-940-3240. Digiview is a digital image management and reporting system with an... on 2008-11-04. The reason FDA records is "Failure of software to update some measurements when tracings or points are amended after measurement calculations have been performed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2166-2011
Status: Terminated
Initiated: 2008-11-04
Posted: 2011-05-10
Terminated: 2011-05-31
Recalling firm: Digisonics, Inc
Product: DigiView software release 3.4.4.4 through 3.5.5.2. , 2008 Digisonics, Inc, 800-940-3240. Digiview is a digital image management and reporting system with an associated clinical database. It provides capture, review and storage of images together with report creation and data basing.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Failure of software to update some measurements when tracings or points are amended after measurement calculations have been performed.
Root cause tag: design
FDA root cause: Device Design
Action: Digisonics, Inc., notified consignees by telephone and e-mail on 10/17/2008, informing them that a problem had been found in the Save Linked Images functionality of DigiView Release 3.6 (and all releases which start with 3.6 such as 3.6.1.). The problem is the failure of the software to update some measurements when tracings or points are amended after measurement calculations have been performed. A utility program, called Linked Image Measurement Verify was being supplied to all sites as a patch to the DigiView program. Release 3.6.6 was to be provided to all customers having previous 3.6 version. Problem was fixed in version 3.6.6 and 3.7.1. If you have any questions, please contact Digisonics Customer Support at (800) 940-3240.
Quantity in commerce: 70 units total
Distribution: Worldwide Distribution -- USA including States of : TX, OH, NC, MA, NY, IL, FL, OK, MO, ID, AZ, AR, MI CA, MD, and country of Canada. *** Due to the age of this recall, district is recommending no audit checks***
Product codes and lots: DigiView software release numbers 3.6.4.4, 3.6.4.6, and 3.6.5.2

Product code LLZ

K970402Class IIDoctors Review SystemDigisonics, Inc. / cleared 1997-03-26

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)