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U.S. Department of Health and Human Services

Enforcement Report - Week of August 8, 2012

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Product Detail

Product Description SoftBank II versions 23.1 and 25.1 applications are decision support software devices. SoftBank II versions 23.1 documents the receipt of inventory from an outside source, multi-side inventory control, records the confirmatory testing on the units and allows for records keeping on component preparation for transfusion.
Recall Number B-1162-12
Classification Class II
Code Info Soft Bank II versions 23.1 and 25.1
Product Distributed Qty 2 products
Reason For Recall Software, with a glitch or defect, was distributed.

Event Detail

Event Id 62021
Product Type Biologics
Status Ongoing
Recalling Firm SCC Soft Computer
City Clearwater
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-11-11
Initial Firm Notification of Consignee or Public Other
Distribution Pattern New York and Michigan
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