Events

Recall of SoftPath

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by SCC Soft Computer.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    35377
  • Event Risk Class
    Class 2
  • Event Number
    Z-1243-06
  • Event Initiated Date
    2004-10-27
  • Event Date Posted
    2006-07-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-07-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45951
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    diagnostic test result software - Product Code JQP
  • Reason
    Text from one case is overwriting another. this could cause an incorrect diagnostic report to be sent to a clinician/surgeon.
  • Action
    Consignees were notified and the products were corrected by the firm.

Device

SoftPath
  • Model / Serial
    Releases 2.3.0 and 4.3.7.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Product was distributed to 4 clients, two in the United States and two in Canada.
  • Product Description
    Product is SoftPath ASCII Software Releases 2.3.0 and 4.3.7. The software is used in pathology labs for administrative and clinicial documentation and data processing.
  • Manufacturer
    SCC Soft Computer

Manufacturer

SCC Soft Computer
  • Manufacturer Address
    SCC Soft Computer, 34350 US Highway 19 N, Palm Harbor FL 34684-2149
  • Source
    USFDA