Blood Establishment Computer Software And Accessories
FDA adverse event reports and recall history for blood establishment computer software and accessories (product code MMH), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,033
- Deaths
- 9
- Injuries
- 19
- Malfunctions
- 973
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2010-11-15TerminatedSoftware design
SoftBank Versions 23.1.2.x, 23.2.0.x, and 25.0.0.x with SoftReports. SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. 23.1:BK040048 23.2:BK080020 25.0:BK090017 The SoftBank II application, using SoftScape user interface, is a decision support software device that requires knowledgeable user intervention to document steps and events in a transfusion service. The application provides single and multiple site facilities the ability to manage their transfusion service by integrating patient and unit information. SoftBank uses an SCC proprietary interface called SoftScape that facilitates access to the application.
SCC Soft Computer is issuing a Correction for SoftBank II Versions: 23.1.2.x, 23.2.0.x, and 25.0.0.x software applications. Functionality issue - For clients generating patient history reports using Patient>Reports>Batch Reports>History Report option in SoftBank with SoftReports activated for patient reports, when the report is generated for more than one patient ALL of the results for the qualif
- TerminatedProcess control
Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475 Product Usage: Esteem Synergy Stomahesive with Flexible Collar 22mm Precut Skin Barrier is used together with Esteem Synergy pouches as an ostomy system intended for the management of stomal output.
It was discovered that the stoma hole of one lots of the Esteem synergy Stomahesive Skin Barrier wafers is larger that the 7/8 inch / 22mm specified on the box label.
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