FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-2180-2011
- Recalling firm
- Digisonics, Inc
- Product
- 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.
- Status
- Terminated
- Initiated
- 2009-01-20
- Posted
- 2011-05-10
- Terminated
- 2011-05-31
- 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.
- Lot, serial or model codes
- DigiView Rel. 3.6.4.4, 3.6.4.6, and 3.6.5.2.
- 510(k) numbers
- K970402
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 1626313
- Firm city
- Houston
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- 3e6df46828c1
- Size
- 288213574 bytes
- Published
- 2026-10-06
- Read
- 2026-10-07T03:20:25.099Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 3e6df46828c1, published 2026-10-06