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
FDA Recall Z-1065-2015 · Posted 2015-02-09
Recalling FirmSCC Soft Computer
Recall StatusTerminated
Product CodeJQP
Date Initiated2014-11-26
Date Terminated2016-05-16
Product Quantity108 units
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.
Firm Action
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.
Root Cause
Software design
Distribution Pattern
Distribution US Nationwide and CANADA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.