Recall Z-1098-2017— Soft Computer Consultants, Inc.
Class II · Terminated
Class II FDA medical device recall by Soft Computer Consultants, Inc., initiated 2016-10-06, terminated 2019-08-21. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Software error. Potential for incorrect results.
- Recalling firm
- Soft Computer Consultants, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-10-06
- Terminated
- 2019-08-21
- Firm location
- Clearwater, FL, United States
Product description
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.
Reason for recall
Software error. Potential for incorrect results
Data sourced from openFDA. This site is unofficial and independent of the FDA.