The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1098-2017·Announced 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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 involves a medical device software error with a potential for incorrect results in a high-risk clinical setting (transfusion services). Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Soft Computer Consultants, Inc. is recalling Softbank software, a decision support system used in transfusion services. The software is used to track inventory from outside sources, manage multi-site inventory, record testing of units, and maintain records for transfusion preparation.

The recall is being conducted because of a software error that creates a potential for incorrect results. The source text does not specify the nature of the error or the specific types of incorrect results that may occur.

The recall affects 189 total units of the software. Distribution was worldwide, including nationwide distribution in the United States across numerous states and territories, as well as Canada and Jamaica. The affected software versions are 35.5.2.0, 25.5.3.0, and 25.5.3.1.

The recalled product

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.
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 (3)

  • Version: 35.5.2.0
  • 25.5.3.0
  • 25.5.3.1

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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