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U.S. Department of Health and Human Services

Class 2 Device Recall SoftPath GUI Versions: 4.3.0.10, 4.3.0.11, and 4.3.0.12.

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 Class 2 Device Recall SoftPath GUI Versions: 4.3.0.10, 4.3.0.11, and 4.3.0.12.see related information
Date Initiated by FirmJune 13, 2011
Date PostedDecember 02, 2011
Recall Status1 Terminated 3 on May 31, 2012
Recall NumberZ-0355-2012
Recall Event ID 60451
Product Classification Medical computers and software - Product Code LNX
ProductSoftPath 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.
Code Information SoftPath GUI Versions: 4.3.0.10, 4.3.0.11, and 4.3.0.12.
Recalling Firm/
Manufacturer		 SCC Soft Computer
5400 Tech Data Drive
Clearwater FL 33760
For Additional Information ContactKathryn Branca
727-789-0100
Manufacturer 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
FDA Determined
Cause 2		Device Design
ActionSCC 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.
Quantity in Commerce14
DistributionClass II Recall - Worldwide Distribution -- USA (nationwide) and the country of Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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