PRIMUS, Accelerator, Linear, Medical The PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
Reason: Software patch installation to address several safety issues.
Z-2877-2016October 5, 2016Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
Syngo.plaza VB10A, Picture Archiving and Communication System
Reason: Software upgrade to eliminate several issues
Z-2892-2016October 5, 2016Malvern, PA
CareFusion 303, Inc.
Class IITerminated
Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syringe Pump module is part of the Alaris System. The syringe pump delivers fluids in a manner similar to current syringe pump...
Reason: A software anomaly with the Alaris Syringe module software version 9.15 may cause an infusion to unexpectedly stop when the Syringe module is transitioning from one rate to another...
Z-2879-2016October 5, 2016San Diego, CA
Siemens Medical Solutions USA, Inc
Class IITerminated
ARTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS branded ARTISTETM family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic trea...
Reason: Software patch installation to address several safety issues.
Z-2876-2016October 5, 2016Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
Syngo.plaza, Picture Archiving and Communication System
Reason: Software upgrade to eliminate several issues
Z-2891-2016October 5, 2016Malvern, PA
Medtronic Inc.
Class IITerminated
CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the iPro2 recorder and blood glucose meter, the CareLink iPro software retrospectively calibrates sensor data and provides rep...
Reason: Medtronic MiniMed is recalling the CareLink iPro Therapy Management Software due to a time stamp error.
Z-2898-2016October 5, 2016Northridge, CA
Siemens Medical Solutions USA, Inc
Class IITerminated
Syngo RT Therapist, Accelerator, Linear, Medical Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It a...
Reason: Software patch installation to address several safety issues.
Z-2878-2016October 5, 2016Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
Reason: Software error. Incorrect values for the volume calculation from a freehand VOI at the customer site. In volume calculations of prostate as well as in volume calculations of liver...
Z-2852-2016September 28, 2016Malvern, PA
Merge Healthcare, Inc.
Class IITerminated
CADstream software. Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream ...
Reason: An incorrect biopsy or missed target could result if the incorrect grid is selected within the application.
Z-2871-2016September 28, 2016Hartland, WI
Hospira Inc.
Class IITerminated
LifeCare PCA Infusion System with Hospira MedNet Software, PCA Serial List Number 20709 Allows for clinician administration or self-administration of analgesic medications.
Reason: Screw rotation error occurring when the pump detects a mismatch between the number of steps given to the motor driving delivery and the number of steps the motor actually took. Whe...
Z-2873-2016September 28, 2016Lake Forest, IL
Siemens Medical Solutions USA, Inc
Class IITerminated
Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
Reason: Software error. Incorrect values for the volume calculation from a freehand VOI at the customer site. In volume calculations of prostate as well as in volume calculations of liver...
Z-2853-2016September 28, 2016Malvern, PA
Merge Healthcare, Inc.
Class IITerminated
Merge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular information system classified as a picture archiving and communications system.
Reason: Patient information in the header is only found on the first page of the report and not on the subsequent pages.
Z-2865-2016September 28, 2016Hartland, WI
Merge Healthcare, Inc.
Class IITerminated
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Reason: Multiple studies were missing at a customer location that never made it to the archive before watermarking
Z-2796-2016September 21, 2016Hartland, WI
Thermo Finnigan LLC
Class IITerminated
Endura MD Mass Spectrometer u using software versions Endura MD Software 1.0 and 1.0 SP1. In vitro diagnostic medical device used to identify and quantify inorganic and organic compounds in the human...
Reason: Thermo Fisher has determined that the Endura MD mass spectrometer instrument control software versions 1.0 and 1.0 SP! have a software defect which affect data accuracy.
Z-2775-2016September 21, 2016San Jose, CA
Hospira Inc., A Pfizer Company
Class IITerminated
Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and 16037-64-03, in combination with the SapphirePlus 13.1x infusion pump Hospira MedNet Medication Manageme...
Reason: Hospira MedNet 6.1 software, in combination with the SapphirePlus 13.1x infusion pump, may result in incorrect bolus amount calculations for drugs whose concentrations are listed i...
Z-2790-2016September 21, 2016Lake Forest, IL
Biosense Webster, Inc.
Class IITerminated
CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versions: v 3.2 , v 4.3 and v 2.3. The CARTO 3 EP Navigation System is intended to be used in catheter-b...
Reason: Biosense Webster, Inc. is initiating a voluntary correction to re-install identified CARTO 3 Systems that were moved and installed in China without testing and approval by Biosense...
Z-2776-2016September 21, 2016Irwindale, CA
Hospira Inc.
Class IITerminated
Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20792. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across t...
Reason: The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
Z-2727-2016September 14, 2016Lake Forest, IL
Philips Medical Systems (Cleveland) Inc
Class IITerminated
BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed Tomography (SPECT)
Reason: The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, rel-180 scan, the detector may come in contact with the patient. The issue was cause...
Z-2736-2016September 14, 2016Cleveland, OH
Philips Medical Systems (Cleveland) Inc
Class IITerminated
BrightView X, model #882478; gamma camera designed for single or dual detector nuclear imaging
Reason: The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, rel-180 scan, the detector may come in contact with the patient. The issue was cause...
Reason: When RadSuite is used with IPID (Issuer of Patient ID) as a part of the "Patient Identifier," it is possible in some circumstances that the demographics of one patient will be appl...
Z-2715-2016September 14, 2016Hartland, WI
Ge Healthcare It
Class IITerminated
Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. Qualified system administrators install, monitor and maintain the system. DICOM devices (e.g. ...
Reason: There is a potential for data loss associated with empty path names resulting from HL-7 updates when the cache disk is almost full. In an unlikely event that the cache disk is almo...
Z-2739-2016September 14, 2016Barrington, IL
Philips Medical Systems (Cleveland) Inc
Class IITerminated
BrightView XCT Upgrade Model 882454
Reason: The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, rel-180 scan, the detector may come in contact with the patient. The issue was cause...
Z-2737-2016September 14, 2016Cleveland, OH
Hospira Inc.
Class IITerminated
Plum A+3 Infusion Pump with Hospira MedNet Software. List Number 20678. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across ...
Reason: The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
Z-2730-2016September 14, 2016Lake Forest, IL
Hospira Inc.
Class IITerminated
Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20679. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across t...
Reason: The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
Z-2726-2016September 14, 2016Lake Forest, IL
Merge Healthcare, Inc.
Class IITerminated
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. RadSuite provides a means to distribute, display, and store diagnostic-quality medical images in electronic format.
Reason: Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (EA) and are not displaying correctly in RadSuite.