DigiView software release 3.4.4.4 through 3.5.5.2. , 2008 Digisonics, Inc, 800-940-3240. Digiview is a digital image man
FDA device recall Z-2166-2011 · posted 2011-05-10 · Terminated
Recall details
- Recalling firm
- Digisonics, Inc
- Reason for recall
- Failure of software to update some measurements when tracings or points are amended after measurement calculations have been performed.
- Action taken
- Digisonics, Inc., notified consignees by telephone and e-mail on 10/17/2008, informing them that a problem had been found in the Save Linked Images functionality of DigiView Release 3.6 (and all releases which start with 3.6 such as 3.6.1.). The problem is the failure of the software to update some measurements when tracings or points are amended after measurement calculations have been performed. A utility program, called Linked Image Measurement Verify was being supplied to all sites as a patch to the DigiView program. Release 3.6.6 was to be provided to all customers having previous 3.6 version. Problem was fixed in version 3.6.6 and 3.7.1. If you have any questions, please contact Digisonics Customer Support at (800) 940-3240.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 70 units total
- Distribution
- Worldwide Distribution -- USA including States of : TX, OH, NC, MA, NY, IL, FL, OK, MO, ID, AZ, AR, MI CA, MD, and country of Canada. *** Due to the age of this recall, district is recommending no aud
- Date initiated
- 2008-11-04
- Date posted
- 2011-05-10
- Date terminated
- 2011-05-31
- Location
- Houston, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DOCTORS REVIEW SYSTEM (K970402) | Digisonics, Inc. | 1997-03-26 |