The Recall Desk

FDA (Devices) recall action 76046

Soft Computer Consultants, Inc. recalled 2 products on 2017-02-01

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2017-02-01
Critical
0
Units
378

Why these products were recalled

Software error. Potential for incorrect results

Software error. Potential for incorrect results

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2017-02-01

    Softbank II Transfusion Software Recalled for Potential Incorrect Results

    Soft Computer Consultants is recalling Softbank II software due to a software error that may produce incorrect results in transfusion services.

    Product
    SCC Soft Computer Softbank II software Product Usage: Supports single and multi-site transfusion services in healthcare facilities. Used by healthcare personal to document, query, and view the integrated information regarding patients and products. Quality control testing…
    Category
    Distribution
    38 states
  • HighFDA (Devices)··2017-02-01

    Softbank Transfusion Software Recalled for Potential Incorrect Results

    Soft Computer Consultants is recalling Softbank decision support software due to a software error that may produce incorrect results.

    Product
    Softbank software Product Usage: Decision support software for transfusion service. It keeps track of inventory from outside sources, multi-site inventory control, records of testing of units, and allows for record keeping for transfusion preparation.
    Category
    Distribution
    38 states