CLASS II Device recall · Reported 1 Feb 2017 · FDA Enforcement Report
Softbank software Product Usage: Decision support software recalled
Soft Computer Consultants is recalling Softbank software Product Usage: Decision support software for, distributed nationwide in the US. The recall was initiated on 6 Oct 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1098-2017
- FDA event ID
- 76046
- Recalling firm
- Soft Computer Consultants, Clearwater, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Oct 2016
- FDA classified
- 26 Jan 2017
- Reported
- 1 Feb 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 6 Oct 2016 | Recall initiated by company | |
| 26 Jan 2017 | Classified by FDA | +112 days |
| 1 Feb 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Software error. Potential for incorrect results
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
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
Nationwide AlabamaArizonaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaHawaiiIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaineMichiganMinnesota
Questions about this recall
Why was it recalled?
Software error. Potential for incorrect results
Which lots are affected?
Version: 35.5.2.0, 25.5.3.0, 25.5.3.1
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 76046This product is part of a recall event; the main page for the event is SCC Soft Computer Softbank II recalled by Soft Computer Consultants.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | SCC Soft Computer Softbank II recalled by Soft Computer Consultants | Soft Computer Consultants | Device Malfunction | Nationwide |
More recalls from Soft Computer Consultants
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | SoftCytogenetics recalled by Soft Computer Consultants | Soft Computer Consultants | Device Malfunction | Nationwide |
| Device | CLASS II | SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow recalled | Soft Computer Consultants | Device Malfunction | CA |
| Device | CLASS II | SoftLab Software Laboratory information system to be used recalled | Soft Computer Consultants | Device Malfunction | 11 states |
| Device | CLASS II | SCC Soft Computer Softbank II recalled by Soft Computer Consultants | Soft Computer Consultants | Device Malfunction | Nationwide |
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| Device | CLASS II | Philips Ingenuity CT recalled by Philips North America | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Philips Brilliance CT 64: Brilliance CT 64 Channel recalled | Philips North America | Device Malfunction | MA |
| Device | ANNOUNCED | BMC Luna G3 APAP recalled by BMC MedicalBMC | BMC Medical | Device Malfunction | Nationwide |