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Recall Observatory FDA recall evidence

Device 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

Z-1065-2015

November 26, 2014

Class II

Product summary

Firm
SCC Soft Computer
Event
Event 69837
Status
Terminated
Classification
Class II
Quantity
108 units
Official record key
device-enforcement:Z-1065-2015

Official wording

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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.