EpiCenter Plus Microbiology Data Management System software version 6.20A, when used in conjunction with the MALDI BioTyper System . Product Usage: The EpiCenter system is a clinical data manageme...
Reason: The information in the EpiCenter interface translation tables was not updated to match the Bruker MALDI BioTyper database identifications for some organisms. This could lead to a p...
Z-1414-2017March 15, 2017Sparks, MD
Merge Healthcare, Inc.
Class IITerminated
DR Systems Unity PACS software, now known as Merge Unity PACS
Reason: Reports were missing demographic header information when they were faxed to referring physicians.
Z-1426-2017March 15, 2017Hartland, WI
Merge Healthcare, Inc.
Class IITerminated
Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI.
Reason: When taking measurements from images on the Cardio workstation or from the US cart, numbers are not crossing to the report in the correct unit of measure.
Z-1403-2017March 15, 2017Hartland, WI
Medtronic Neuromodulation
Class ITerminated
Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N'Vision Clinician Programmer, and Model 8637 SynchroMed II Implanta...
Reason: Medtronic is following up to a May 2013 communication regarding the Priming Bolus function for the SynchroMed Infusion System. Medtronic is updating the Model 8870 software applic...
Z-0788-2017March 8, 2017Minneapolis, MN
Merge Healthcare, Inc.
Class IITerminated
DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usage: Merge Unity PACS is a medical image and information management system that allows viewing, selection, processing, prin...
Reason: The software is not adding the correct tomo image.
Z-1385-2017March 8, 2017Hartland, WI
Tosoh Smd Inc
Class IITerminated
Keyspan High-High Speed USB to Serial Adapter Product Usage: The Reporting Software is an application which serves as middle ware between the Tosoh Automated HPLC G8 analyzer and an LIS or as a st...
Reason: Power outages causes reporting software to shutdown.
Z-1245-2017March 1, 2017Grove City, OH
BioMerieux SA
Class IITerminated
VIDAS 3 software v. 1.1.4
Reason: During development of the VIDAS 3 software version 1.2, some anomalies have been identified and observed to be already present in the current software version VIDAS 3 version 1.1.4...
Z-1200-2017February 22, 2017Marcy L'Etoile, N/A
Merge Healthcare, Inc.
Class IITerminated
The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge Hemo software.
Reason: Non-invasive blood pressure pumps (NIBP) voltage is not sufficient and causes the NIBP pumps to fail prior to reaching adequate initial pressure.
Z-1203-2017February 22, 2017Hartland, WI
Siemens Healthcare Diagnostics, Inc.
Class IITerminated
CentraLink¿ Data Management System Software Versions: v13x,v14x,v15x The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automat...
Reason: There is a remote possibility CentraLink may download an order to the ADVIA Automation System without specifying the sample type. This can occur when an order is received from the ...
Z-1204-2017February 22, 2017Tarrytown, NY
Merge Healthcare, Inc.
Class IITerminated
Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Reason: The values provided from the Pixel Value tool do not appear to be correct, which may result in potential patient injury or delay in diagnosis or treatment.
Z-1180-2017February 15, 2017Hartland, WI
Merge Healthcare, Inc.
Class IITerminated
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
Reason: Potential exists for an incorrect patient image being displayed which could result in the delay in diagnosis or treatment.
Z-1176-2017February 15, 2017Hartland, WI
Siemens Medical Solutions USA, Inc
Class IITerminated
Syngo.plaza, picture archiving and communications system.
Reason: Software update for improvements and to resolve several issues
Z-1116-2017February 8, 2017Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies...
Reason: Software error
Z-1118-2017February 8, 2017Malvern, PA
Soft Computer Consultants, Inc.
Class IITerminated
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...
Reason: Software error. Potential for incorrect results
Z-1098-2017February 1, 2017Clearwater, FL
Roche Diagnostics Operations, Inc.
Class IITerminated
Cobas b 123 POC system The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes Nat, K+, iCaWt (ISE), hematocrit (THct), ...
Reason: under specific settings, an issue may occur during simultaneous Sensor Cartridge and Fluid Pack change on the cobas b 123 <2> POC system and cobas b 123 <4> POC system. The issue ...
Z-1077-2017February 1, 2017Indianapolis, IN
PerkinElmer Health Sciences, Inc.
Class IIITerminated
DELFIA¿ PC with V3.0 Software, Fluorometer, for clinical use Product Number: 1235-8100 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perfor...
Reason: AutoDELFIA System with Version 3.0 Software: Potential plate loading failures
Z-1102-2017February 1, 2017Waltham, MA
PerkinElmer Health Sciences, Inc.
Class IIITerminated
Program Update Package AutoDELFIA¿ 3.0, Fluorometer, for clinical use Product Number: 1235-8110 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automaticall...
Reason: AutoDELFIA System with Version 3.0 Software: Potential plate loading failures
Z-1101-2017February 1, 2017Waltham, MA
PerkinElmer Health Sciences, Inc.
Class IIITerminated
AutoDELFIA¿ Plate Processor , Fluorometer, for clinical use Product Number: 1235-5110 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perfo...
Reason: AutoDELFIA System with Version 3.0 Software: Potential plate loading failures
Z-1100-2017February 1, 2017Waltham, MA
Roche Diabetes Care, Inc.
Class IITerminated
Accu-Chek Connect Diabetes Management App
Reason: iOS and Android: Under certain conditions the affected app versions may disregard historical bolus data potentially leading to an incorrect bolus insulin recommendation being provi...
Z-1099-2017February 1, 2017Indianapolis, IN
Soft Computer Consultants, Inc.
Class IITerminated
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 int...
Reason: Software error. Potential for incorrect results
Z-1097-2017February 1, 2017Clearwater, FL
Merge Healthcare, Inc.
Class IITerminated
Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure
Reason: There is a potential connection issue when powering up the Merge Hemo Record Station and the Hemo Monitor does not communicate with the Client PC.
Z-1091-2017February 1, 2017Hartland, WI
Merge Healthcare, Inc.
Class IITerminated
Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and ...
Reason: If a reader selects Multi-study review prior to the original study completing its loading process and then immediately returns to image review of the original study, it is possible...
Z-1046-2017January 25, 2017Hartland, WI
The Binding Site Group, Ltd.
Class IITerminated
Digital RID Plate Reader and Software Product Code: AD400
Reason: If a control ring is marked after reading, the software will not flag results that are out of the specified QC range.
Z-1055-2017January 25, 2017Birmingham
Carestream Health Inc
Class IITerminated
Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System Diagnostic ultrasound imaging or fluid flow analysis of the human body
Reason: Software error; Carestream Health Inc, received a complaint stating that when a user accidentally obtains a measurement value of 0 and corrects the value in the report, the resulti...
Z-1052-2017January 25, 2017Rochester, NY
DICOM GRID INC
Class IITerminated
Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number: V3.16.13.0 Intended for use as a primary diagnostic and analysis tool for diagnostic images.
Reason: A software error caused the window/level to become the same in one series regardless if the image had different levels; image results have a washed-out grey appearance.