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.
This recall has been terminated (originally issued May 13, 2011).
- Company
- Digisonics, Inc
- Recall Initiated
- February 6, 2009
- Posted
- May 13, 2011
- Terminated
- May 31, 2011
- Recall Number
- Z-2193-2011
- Quantity
- 74 units
- Firm Location
- Houston, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Left ventricle volume was inaccurate when the volumes were measured from images having different scales.
Distribution
Worldwide distribution: USA (Nationwide) and countries of: Canada, Lebanon and New Zealand.
Lot / Code Info
DigiView software release numbers 3.6.44, 3.6.4.6, and 3.6.5
Root Cause
Other
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