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Recall Observatory FDA recall evidence

Device 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.

Z-1098-2017

October 06, 2016

Class II

Product summary

Firm
Soft Computer Consultants, Inc.
Event
Event 76046
Status
Terminated
Classification
Class II
Quantity
189 total
Official record key
device-enforcement:Z-1098-2017

Official wording

Reason: Software error. Potential for incorrect results

Code information: Version: 35.5.2.0, 25.5.3.0, 25.5.3.1

Distribution pattern: Worldwide 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

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    Software error. Potential for incorrect