SCC Soft Computer: Medical Device Recall in 2015 - (Recall #: Z-1065-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: November 26, 2014

Date Posted: February 18, 2015

Recall Number: Z-1065-2015

Event ID: 69837

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.

Status: Terminated

Product Quantity: 108 units

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;

Distribution Pattern:

Distribution US Nationwide and CANADA.

Voluntary or Mandated:

Voluntary: Firm initiated