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

FDA device recall Z-2193-2011 · posted 2011-05-13 · Terminated

Recall details

Recalling firm

Digisonics, Inc

Reason for recall

Left ventricle volume was inaccurate when the volumes were measured from images having different scales.

Action taken

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

Root cause

Other

Status

Terminated

Product code

LLZ

Quantity affected

74 units

Distribution

Worldwide distribution: USA (Nationwide) and countries of: Canada, Lebanon and New Zealand.

Date initiated

2009-02-06

Date posted

2011-05-13

Date terminated

2011-05-31

Location

Houston, TX

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