SoftPath Laboratory Information System. Versions 4.3.0.8, 4.3.0.9, 4.3.0.10, 4.3.0.11, 4.3.0.12, 4.3.0.14, 4.3.0.15, and 4.4.0.0
This recall has been terminated (originally issued February 9, 2015).
- Company
- Scc Soft Computer
- Recall Initiated
- November 26, 2014
- Posted
- February 9, 2015
- Terminated
- May 16, 2016
- Recall Number
- Z-1065-2015
- Quantity
- 108 units
- Firm Location
- Clearwater, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Modifications to diagnostic text may be: 1) Saved to the database but not appear on the report sent to the physician; or 2) Documented on the report, but not saved to the database.
Distribution
Distribution US Nationwide and CANADA.
Lot / Code Info
Version 4.3.0.8 Release date: 07/31/2009 - Present; Version 4.3.0.9 Release date: 11/23/2009 - Present; Version 4.3.0.10 Release date: 09/20/2010- Present; Version 4.3.0.11 Release date: 11/11/2010- Present; Version 4.3.0.12 Release date: 02/07/2011- Present; Version 4.3.0.14 Release date: 11/14/2012- Present; Version 4.3.0.15 Release date: 09/17/2013- Present; Version 4.4.0.1 Release date: 12/13/2013 - Present;
Root Cause
Software design
Action Taken
On 11/26/2014 SCC Soft Computer sent a Correction Communication to their consignees: Corrective Action: Versions 4.3.0.8 through 4.4.0.2 will have a mandatory hotfix created. Due to the amount of versions affected, the range of availability dates will be 11/24/2014 through 12/30/2014. Utility: A utility will be made available to be run on your Live system that will identify cases in which there is a disparity between the diagnosis text in the document and the database. The utility output will be provided for client review and validation.