Events

Recall of Device Recall 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
    35375
  • Event Risk Class
    Class 2
  • Event Number
    Z-1252-06
  • Event Initiated Date
    2001-01-09
  • Event Date Posted
    2006-07-26
  • 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=45949
  • 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
    pathology lab software - Product Code JQP
  • Reason
    The client had made a decision to use the softpath module in a nonstandard manner. under specific circumstances, incorrect text may appear on a patient report.
  • Action
    The firm issued a software correction letter to its consignees 1/9/2001, advising them of the problem and supplied them with a software patch ICC number 3618 also referred to as release 3.0. The firm advised its clients that the installation of this software to their system was mandatory.

Device

Device Recall SoftPath
  • Model / Serial
    Releases 1.2, 2.1, and 2.3
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada.
  • Product Description
    SoftPath ASCII Software, used in pathology labs to track and report specimens and diagnostic results. Releases 1.2, 2.1, and 2.3
  • 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