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

FDA device recall Z-1065-2015 · posted 2015-02-09 · Terminated

Recall details

Recalling firm

SCC Soft Computer

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.

Action taken

On 11/26/2014 SCC Soft Computer sent a Correction Communication to their consignees: Corrective Action: Versions 4.3.0.8 through 4.4.0.2 will have a mandatory hotfix created. Due to the amount of versions affected, the range of availability dates will be 11/24/2014 through 12/30/2014. Utility: A utility will be made available to be run on your Live system that will identify cases in which there is a disparity between the diagnosis text in the document and the database. The utility output will be provided for client review and validation.

Root cause

Software design

Status

Terminated

Product code

JQP

Quantity affected

108 units

Distribution

Distribution US Nationwide and CANADA.

Date initiated

2014-11-26

Date posted

2015-02-09

Date terminated

2016-05-16

Location

Clearwater, FL