SoftPath GUI Versions: 4.3.0.10, 4.3.0.11, and 4.3.0.12. SoftPath is a laboratory information system to be used in a cli

FDA device recall Z-0355-2012 · posted 2011-12-02 · Terminated

Recall details

Recalling firm

SCC Soft Computer

Reason for recall

On 06/13/2011, SCC Soft Computer initiated a correction on the following SoftPath GUI Versions: 4.3.0.10, 4.3.0.11, and 4.3.0.12. A client reported when they verified the contents of the fax reports, they found one of the specimen diagnoses to be missing. Parts A through D were present as well as Part F, however, Part E diagnosis was missing for one of the patient reports. All affected clients wer

Action taken

SCC Soft Computer initiated a Field Correction on June 13, 2011. All customers with affected software have been notified of this issue. SCC recommends until the corrected patch is loaded to temporarily use one of the following alternative working solutions: 1. Use MS Word Editor functionality within SoftPath application for creating patient reports. In order to ensure Text Control editor is not inadvertently activated, the templates for Text Control editor will be deleted and reinstalled at the clients request by their SCC representative after receipt of the correction. 2. In Report Template set-up, the bottom margin should be made slightly larger than the size of the footer plus its distance from the bottom page border. For further explanation, please consult your SCC representative for further details, or call (727) 789-0100.

Root cause

Device Design

Status

Terminated

Product code

LNX

Quantity affected

14

Distribution

Class II Recall - Worldwide Distribution -- USA (nationwide) and the country of Canada.

Date initiated

2011-06-13

Date posted

2011-12-02

Date terminated

2012-05-31

Location

Clearwater, FL