Cl II SoftPath Laboratory Information System

Company:SCC Soft Computer
Date of Enforcement Report: 2/18/2015
Class lI:

PRODUCT

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
Recall Number Z-1065-2015

REASON
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/MANUFACTURER
SCC Soft Computer, Clearwater, FL on 11/262014 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
108

DISTRIBUTION
Nationwide and Canada

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CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.