The Recall Desk
HighFDA (Devices)·Z-1097-2017·Announced 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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical software) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Soft Computer Consultants, Inc. is recalling Softbank II software, which supports transfusion services in healthcare facilities. The recall is due to a software error that creates a potential for incorrect results.

The affected software versions are 23.1.2, 23.2.0, 25.0.0, 25.1.0, 25.2.0, and 25.3.0. A total of 189 units were distributed worldwide, including across the United States, Canada, and Jamaica. The software is used by healthcare personnel to document, query, and view information regarding patients and products, as well as to monitor quality control testing and transfusion management.

Healthcare facilities using this software should contact Soft Computer Consultants, Inc. for further instructions on how to address the software error.

The recalled product

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, te
Manufacturer
Soft Computer Consultants, Inc.
Category
Medical Device — Software
Hazard
Affected units
189

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • Version: 23.1.2
  • 23.2.0
  • 25.0.0
  • 25.1.0
  • 25.2.0
  • 25.3.0

Distribution

Distributed nationwide across the United States.

The notice also names 38 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Soft Computer Consultants, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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