Z-2180-2011

Digisonics, DigiView and ERS software release 3.6.4.4 through 3.6.5.2+, 2008 Digisonics, Inc., 3701 Kirby...

Name: Z-2180-2011 Digisonics, DigiView and ERS software release 3.6.4.4 through 3.6.5.2+, 2008 Digisonics, Inc., 3701 Kirby...
Creator: Digisonics, Inc
Published: 2009-01-20
License: https://open.fda.gov/license/

Digisonics, Inc / initiated 2009-01-20 / Terminated / root cause: design

FDA source

Digisonics, Inc began a recall of Digisonics, DigiView and ERS software release 3.6.4.4 through 3.6.5.2+, 2008 Digisonics, Inc., 3701 Kirby Drive, Houston TX 77098, 800-940-3240. DigiView is a... on 2009-01-20. The reason FDA records is "Data from one patient's study had the potential for being put into another patient's report". 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-2180-2011
Status: Terminated
Initiated: 2009-01-20
Posted: 2011-05-10
Terminated: 2011-05-31
Recalling firm: Digisonics, Inc
Product: Digisonics, DigiView and ERS software release 3.6.4.4 through 3.6.5.2+, 2008 Digisonics, Inc., 3701 Kirby Drive, Houston TX 77098, 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: Data from one patient's study had the potential for being put into another patient's report.
Root cause tag: design
FDA root cause: Device Design
Action: Digisonics notified end users via e-mail January 20, 2009 and January 21, 2009, that Data from one patient's study was being put into another patient's report. The problem occurred when a System bug was found in DigiView Release 3.6.4.4, and higher versions in which under certain circumstances (specific workflow) a failure to switch to a patient's images occurs. Two software patch versions will be made available to sites on or after February 5, 2009, to correct the reported problem. If you have any further questions, please contact Digisonics Customer Support at (800 ) 940-3240.
Quantity in commerce: 70 units
Distribution: Worldwide Distribution -- USA including States of : OH, NC, LA, TX, CA, MO, NY, MD, MA, DC, IA, AZ, PA, MI, NC, FL, IN, SC, ID, MN, AR, OK, IL, CT, and countries of Canada, Lebanon, and New Zealand.
Product codes and lots: DigiView Rel. 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)