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U.S. Department of Health and Human Services

Class 2 Device Recall Softbank 25.5.2.025.5.3.1

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 Class 2 Device Recall Softbank 25.5.2.025.5.3.1see related information
Date Initiated by FirmOctober 06, 2016
Create DateJanuary 26, 2017
Recall Status1 Terminated 3 on August 21, 2019
Recall NumberZ-1098-2017
Recall Event ID 76046
Product Classification Software, transmission and storage, patient data - Product Code NSX
ProductSoftbank 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.
Code Information Version: 35.5.2.0, 25.5.3.0, 25.5.3.1
Recalling Firm/
Manufacturer		 Soft Computer Consultants, Inc.
5400 Tech Data Dr
Clearwater FL 33760-3116
For Additional Information ContactTechnical Support
800-763-8522
Manufacturer Reason
for Recall		Software error. Potential for incorrect results
FDA Determined
Cause 2		Software design (manufacturing process)
ActionConsignees were sent a recall notification, dated 10/06/2016, providing instructions for software correction. The firm indicates that the issue will be resolved with a mandatory hot fix. Hot fix will be released when its effectiveness is confirmed. Consignees are instructed to acknowledge receipt of the recall notification and grant permission for the recalling firm to load the hot fix when available. The firm can be contacted by calling Technical Support at 1-800-763-8522. Until the hot fix is available, consignees can still operate the software by exiting (Esc-Quit) the Test Verify option after each save changes (F12-Accept).
Quantity in Commerce189 total
DistributionWorldwide Distribution - US Nationwide Distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WA, WI, WV, and the countries of Hawaii and Puerto Rico Canada & Jamaica
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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