Recall Z-2193-2011 ยท LLZ System, Image Processing, Radiological
Digisonics, Inc
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.
| Date | May 13, 2011 (initiated Feb 6, 2009) |
| Status | Terminated |
| Reason | Left ventricle volume was inaccurate when the volumes were measured from images having different scales. |
| 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 |
| Quantity | 74 units |
| Distribution | Worldwide distribution: USA (Nationwide) and countries of: Canada, Lebanon and New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970402 | DOCTORS REVIEW SYSTEM Digisonics, Inc., Mar 26, 1997 |