Digisonics, DigiView and ERS software release 3.6.4.4 through 3.6.5.2+, 2008 Digisonics, Inc., 3701 Kirby Drive, Houston
FDA device recall Z-2180-2011 · posted 2011-05-10 · Terminated
Recall details
- Recalling firm
- Digisonics, Inc
- Reason for recall
- Data from one patient's study had the potential for being put into another patient's report.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 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.
- Date initiated
- 2009-01-20
- Date posted
- 2011-05-10
- Date terminated
- 2011-05-31
- Location
- Houston, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DOCTORS REVIEW SYSTEM (K970402) | Digisonics, Inc. | 1997-03-26 |