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,...
FDA Recall #Z-1065-2015 — Class II — November 26, 2014
Product Description
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
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.
Recalling Firm
SCC Soft Computer — Clearwater, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
108 units
Distribution
Distribution US Nationwide and CANADA.
Code Information
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;
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated