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.
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 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…
- Manufacturer
- Soft Computer Consultants, Inc.
- Category
- Medical Device — Software
- 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
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 →Related recalls
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