Recall Z-2180-2011 ยท LLZ System, Image Processing, Radiological
Digisonics, Inc
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.
| Date | May 10, 2011 (initiated Jan 20, 2009) |
| Status | Terminated |
| Reason | Data from one patient's study had the potential for being put into another patient's report. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970402 | DOCTORS REVIEW SYSTEM Digisonics, Inc., Mar 26, 1997 |