RecallRadar

FDA Device recall Z-1097-2017

SCC Soft Computer Softbank II software Product Usage: Supports single and multi-site transfusion services in healthcare facilities

On 2017-02-01 the FDA classified a Class II recall of SCC Soft Computer Softbank II software Product Usage: Supports single and multi-site transfusion services in healthcare facilities by Soft Computer Consultants, citing software error. Potential for incorrect results.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1097-2017
ClassificationClass II
Statusterminated
Initiated2016-10-06
Published2017-02-01
Last updated2026-09-13 11:54 UTC
CompanySoft Computer Consultants
DistributionUS

Product

SCC Soft Computer Softbank II software Product Usage: Supports single and multi-site transfusion services in healthcare facilities. Used by healthcare personal to document, query, and view the integrated information regarding patients and products. Quality control testing, test and transfusion history, transfusion management, inventory management, product distribution, and final disposition are all monitored using the software.

Reason

Software error. Potential for incorrect results

Identifiers

code_infoVersion: 23.1.2, 23.2.0, 25.0.0, 25.1.0, 25.2.0, 25.3.0

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1097-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.