GEMINI TF 64 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suita...
Reason: Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased t...
Z-2196-2015July 29, 2015Cleveland, OH
Volcano Corporation
Class IITerminated
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5i Radiology: The Volcano s5/s5i and...
Reason: A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
Z-2134-2015July 29, 2015Rancho Cordova, CA
Philips Medical Systems (Cleveland) Inc
Class IITerminated
GEMINI TF Ready CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable...
Reason: Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased t...
Z-2197-2015July 29, 2015Cleveland, OH
Volcano Corporation
Class IITerminated
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model CORE Radiology: The Volcano s5/s5i an...
Reason: A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
Z-2136-2015July 29, 2015Rancho Cordova, CA
Volcano Corporation
Class IITerminated
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5ix/s5iz Radiology: The Volcano s5/s...
Reason: A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
Z-2135-2015July 29, 2015Rancho Cordova, CA
Volcano Corporation
Class IITerminated
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5x. Radiology: The Volcano s5/s5i and...
Reason: A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
Z-2132-2015July 29, 2015Rancho Cordova, CA
Philips Medical Systems (Cleveland) Inc
Class IITerminated
GEMINI GXL 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suit...
Reason: Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased t...
Z-2193-2015July 29, 2015Cleveland, OH
Philips Medical Systems (Cleveland) Inc
Class IITerminated
GEMINI TF Big Bore CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suita...
Reason: Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased t...
Z-2199-2015July 29, 2015Cleveland, OH
Philips Medical Systems (Cleveland) Inc
Class IITerminated
GEMINI TF Base CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable ...
Reason: Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased t...
Z-2198-2015July 29, 2015Cleveland, OH
Volcano Corporation
Class IITerminated
Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5. Radiology: The Volcano s5/s5i a...
Reason: A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
Z-2131-2015July 29, 2015Rancho Cordova, CA
Viewray Incorporated
Class IITerminated
Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when ...
Reason: ViewRay received a report that the couch moved unexpectedly into the bore after performing a RTCS reboot.
Z-2085-2015July 22, 2015Oakwood Village, OH
Siemens Healthcare Diagnostics, Inc.
Class IITerminated
Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Intelligent Lab System software version 3.6.1. In vitro diagnostic analyzer.
Reason: Two software issues may occur in Vista software version 3.6.1. Issue #1: Samples may stop processing without notification. Issue #2: Timing issue in Vista 1500 may cause wrong rea...
Z-2054-2015July 15, 2015Newark, DE
Viewray Incorporated
Class IITerminated
Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body wh...
Reason: The software was failing to determine new patient locations if imaging is not enabled during treatment.
Z-1954-2015July 8, 2015Oakwood Village, OH
Siemens Healthcare Diagnostics, Inc.
Class IITerminated
EasyLink Data Management System; a clinical data management system that assists medical laboratory professionals with preanalytic and post-analytic functions in conjunction with multiple instruments, ...
Reason: System Limitations and Software Issues related to the following features: Custom reference ranges, User-initiated sample and result actions, Auto-verification and quality control ...
Z-1942-2015July 8, 2015Newark, DE
Siemens Healthcare Diagnostics, Inc.
Class IITerminated
CentraLink" Data Management System; software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software c...
Reason: Siemens Healthcare Diagnostics has determined that the sample query function that includes Instrument or Instrument Group as search criteria may not return all samples from the...
Z-1957-2015July 8, 2015Newark, DE
Siemens Medical Solutions USA, Inc.
Class IITerminated
ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option. Model number 10433816: The SC2000 ultrasound imaging system is intended for the followin...
Reason: When performing a 2D Stress Echo study, some following keystrokes result in a potential loss of data, where some selected clips may not be saved as part of the study.
Z-1959-2015July 8, 2015Mountain View, CA
Siemens Medical Solutions USA, Inc
Class IITerminated
Artis zee/ zeego systems; Product Usage: Usage: Artis zee/ zeego systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures inclu...
Reason: There exists a possible position sensor fault in the swivel base axis not being detected by the system software. When moving, the system could potentially exceed its usual speed, r...
Z-1846-2015July 1, 2015Malvern, PA
CareFusion 303, Inc.
Class IITerminated
Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The softwa...
Reason: An issue with the cancel functionality used during atypical infusion programming to cancel user inputted values. An infusion may start that is greater than or less than the hospit...
Z-1811-2015June 24, 2015San Diego, CA
Philips Ultrasound, Inc.
Class IITerminated
Philips Ultrasound, Model Q-Station, with software version 3 or higher, Catalog number: 795088; Part Number: 989605382391 Q-Station is application software intended to manage, view, analyze, and r...
Reason: Philips Healthcare has discovered a problem in the Philips Ultrasound Q-Station version 3.0 or higher that could result in measurements from a study (Structured Report) to be appe...
Z-1807-2015June 24, 2015Bothell, WA
Ortho-Clinical Diagnostics
Class IITerminated
VITROS 5600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use.
Reason: Software anomaly allows testing of multiple assays using a single urine specimen, regardless of the pretreatment requirements for each selected assay, potentially leading to biased...
Z-1743-2015June 17, 2015Rochester, NY
Ortho-Clinical Diagnostics
Class IITerminated
Assay Data Disk (ADD), All DRV versions that support product within expiry dating Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. VITROS Urine A...
Reason: Software anomaly regarding urine samples that require acidified pretreatment. The software has allowed urine samples for assays that require acidified pretreatment to be metered f...
Z-1729-2015June 17, 2015Rochester, NY
Ortho-Clinical Diagnostics
Class IITerminated
VITROS 5,1 FS Chemistry System, Software Version 2.8 & Below Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. VITROS Urine Assays: VITROS Calcium...
Reason: Software anomaly regarding urine samples that require acidified pretreatment. The software has allowed urine samples for assays that require acidified pretreatment to be metered f...
Z-1728-2015June 17, 2015Rochester, NY
Ortho-Clinical Diagnostics
Class IITerminated
VITROS 4600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use.
Reason: Software anomaly allows testing of multiple assays using a single urine specimen, regardless of the pretreatment requirements for each selected assay, potentially leading to biased...
Z-1742-2015June 17, 2015Rochester, NY
Elekta, Inc.
Class IITerminated
Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.
Reason: Incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series.
Z-1712-2015June 10, 2015Atlanta, GA
Siemens Medical Solutions USA, Inc
Class IITerminated
Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
Reason: measurements drawn on the 2nd and subsequent images of the series are not visible on printouts when the series is sent to print.