Z-1065-2015 Class II Terminated
FDA device recall Z-1065-2015 was initiated by SCC Soft Computer on November 26, 2014 and is designated Class II. 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. The recall status is terminated (terminated May 16, 2016). Affected quantity: 108 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 18, 2015
- Initiation Date
- November 26, 2014
- Termination Date
- May 16, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 108 units
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.
Distribution Pattern
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;