Z-2193-2011

Digisonics, Digiview and ERS software releases 3.6.44, 3.6.4.6, and 3.6.5, Digisonics, Inc., 3701 Kirby...

Name: Z-2193-2011 Digisonics, Digiview and ERS software releases 3.6.44, 3.6.4.6, and 3.6.5, Digisonics, Inc., 3701 Kirby...
Creator: Digisonics, Inc
Published: 2009-02-06
License: https://open.fda.gov/license/

Digisonics, Inc / initiated 2009-02-06 / Terminated

FDA source

Digisonics, Inc began a recall of Digisonics, Digiview and ERS software releases 3.6.44, 3.6.4.6, and 3.6.5, Digisonics, Inc., 3701 Kirby Drive, Houston, TX 77098, Tel: (800) 940-3240, Fax... on 2009-02-06. The reason FDA records is "Left ventricle volume was inaccurate when the volumes were measured from images having different scales". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2193-2011
Status: Terminated
Initiated: 2009-02-06
Posted: 2011-05-13
Terminated: 2011-05-31
Recalling firm: Digisonics, Inc
Product: Digisonics, Digiview and ERS software releases 3.6.44, 3.6.4.6, and 3.6.5, Digisonics, Inc., 3701 Kirby Drive, Houston, TX 77098, Tel: (800) 940-3240, Fax: (713) 529-7999 Software used to make on-screen (2-D, M-Mode and Doppler) measurements of left ventricle, right ventricle, etc.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Left ventricle volume was inaccurate when the volumes were measured from images having different scales.
FDA root cause: Other
Action: The firm, Digisonics, notified consignees/customers via e-mail entitled "Distribution of Notification of Biplane Error" dated February 6, 2009. The email described the product, problem and actions to be taken. The customers were instructed to immediately contact Digisonics if their site calculates biplane volumes-a utility will be provided which will run on their database and identify all studies in which biplane volumes are calculated. The customers were also instructed to share the following important information with all users of DigiView at their site. The email stated -until the software patch has been installed, biplane volumes should be calculated only from pairs of images having the same depth scale. Replacement DigiView/ERS software that prevents further occurrence of this problem will be provided if it appears their site could be impacted. The Distribution of New Software Release was sent on March 6, 2009. If you have any questions, please call Digisonics Customer Support at 800-344-4266
Quantity in commerce: 74 units
Distribution: Worldwide distribution: USA (Nationwide) and countries of: Canada, Lebanon and New Zealand.
Product codes and lots: DigiView software release numbers 3.6.44, 3.6.4.6, and 3.6.5

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)