FDA Medical Device Recalls (openFDA)
SCC Soft Computer: SoftPath GUI version 4.2.3.4 2008-06-30 (Manuf Date). SoftPath GUI version 4.2.4.1 2008-09-30 (Manuf Date). SoftPath GUI version 4.3.0.3, 2008-07-23 (Manuf Date). SoftPath GUI version 4.3.0.4 2008-09-16 (Manuf Date). SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760.
- Recall number
- Z-0102-2011
- Recalling firm
- SCC Soft Computer
- Product
- SoftPath GUI version 4.2.3.4 2008-06-30 (Manuf Date). SoftPath GUI version 4.2.4.1 2008-09-30 (Manuf Date). SoftPath GUI version 4.3.0.3, 2008-07-23 (Manuf Date). SoftPath GUI version 4.3.0.4 2008-09-16 (Manuf Date). SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760.
- Status
- Terminated
- Initiated
- 2009-01-26
- Posted
- 2010-10-20
- Terminated
- 2010-11-03
- Reason
- For SoftPath GUI versions 4.2.3.4, 4.2.4.1, 403.0.3, and 4.3.0.4., the Previous Patient History and some QA Management reports may have missing or incorrect diagnosis text. However, the patient final report, HIS resulting and Query display are all correct. All affected clients have been provided corrected software..
- Root cause
- Software design
- Action
- SCC Soft Computer issued a Risk-to-Health notification with Client Notification Verbiage to affected clients using SCC Soft Computer's proprietary Task Management System on January 26, 2009. SCC issued a software upgrade with corrective patch electronically to all clients. Client was asked to acknowledge receipt of the task and grant permission to load the required software. SCC will contact each client to coordinate the running of the utility and the loading and validation of the correct patch.
- Quantity
- 52
- Distribution
- Worldwide Distribution: Throughout USA and Canada.
- Lot, serial or model codes
- SoftPath GUI versions 4.2.3.4, 4.2.4.1, 4.3.0.3, 4.3.0.4.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LNX
- Firm FEI
- 1000307651
- Firm city
- Clearwater
- Firm state
- FL
- 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
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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 b87518bfe2e8, published 2026-09-28