Devices

Device Recall SoftPath GUI Versions: 4.3.0.10, 4.3.0.11, and 4.3.0.12.

Model / Serial
SoftPath GUI Versions: 4.3.0.10, 4.3.0.11, and 4.3.0.12.
Product Classification
General Hospital and Personal Use Devices
Device Class
Unclassified
Implanted device?
No
Distribution
Class II Recall - Worldwide Distribution -- USA (nationwide) and the country of Canada.
Product Description
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 clinical laboratory by knowledgeable, trained, and experienced personnel. SoftPath enables the user to document steps in the receiving and processing of surgical, gynecological, medical cytological, and autopsy case specimens within the Pathology labs, for the purpose of generating Pathology reports for requesting physicians and label creation for identification of specimen/case material.
Manufacturer
SCC Soft Computer
1 Event
- Recall of Device Recall SoftPath GUI Versions: 4.3.0.10, 4.3.0.11, and 4.3.0.12.

Manufacturer

SCC Soft Computer

Manufacturer Address
SCC Soft Computer, 5400 Tech Data Drive, Clearwater FL 33760
Manufacturer Parent Company (2017)
Soft Computer Consultants Inc.
Source
USFDA

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