EPIQ 7 Ultrasound System, EPIQ 7 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Model: EPIQ 7G, EPIC 7C, EPIQ 7W; Catalog Number: 795200 / 795201 and ...
Reason: When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) applications, the reported End-Systolic Volume (ESV) may be smaller, and the Left Ve...
Z-0817-2015December 24, 2014Bothell, WA
MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
Class IITerminated
VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.
Reason: Software Anomaly. The VERO MHI-TM2000 Operator Console may provide Patient Positioning System (ExacTrac) with Image Angle Information Used for the 1st Port Image, for a subsequent ...
Z-0821-2015December 24, 2014HIROSHIMA, N/A
Philips Medical Systems, Inc.
Class IITerminated
Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The Brilliance iCT/Brilliance iCT SP is a Computed Tomography X-Ray System intended to produce crosssectional images of the b...
Reason: It was discovered that a software defect may result in the scanner not terminating the CT scan at the intended location.
Z-0236-2015December 24, 2014Andover, MA
Carestream Health, Inc.
Class IITerminated
CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
Reason: Reduced mammographic image quality when attempting to print true size multi-format images
Z-0820-2015December 24, 2014Rochester, NY
Mevion Medical Systems, Inc.
Class IITerminated
MEVION S250, used for proton radiation therapy.
Reason: Software defect that causes an incorrect dose compensation function to be applied to the internal dose ionization chamber when either pressure or temperature sensor malfunction. T...
Z-0588-2015December 17, 2014Littleton, MA
INO Therapeutics (dba Ikaria)
Class IITerminated
INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO...
Reason: An issue has been identified in the INOmax DSIR system that could result in monitored Nitric Oxide (NO) concentration reporting lower than expected. This issue only pertains to th...
Z-0575-2015December 17, 2014Madison, WI
TomoTherapy Incorporated
Class IITerminated
TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (Hi:Art 5.0.1 / 5.0.2 / 5.0.3)
Reason: Accuray has become aware of a potential safety issue related to the TomoTherapy Treatment System caused by a failure to monitor the jaw position after a jaw error occurs. This may...
Z-0507-2015December 17, 2014Madison, WI
Siemens Medical Solutions USA, Inc
Class IITerminated
The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems.
Reason: There is a potential issue on running Artis systems running software VC1x software if a network problem arises, the function cannot be deactivated again by pressing the "Block...
Z-0486-2015December 10, 2014Malvern, PA
Abbott Molecular
Class IITerminated
Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing.
Reason: Some versions of Application Specifications (App Spec) are incompatible with m2000sp system software version 6.0 and 7.0. This issue will cause Error Code 9000 (An unexpected error...
Z-0463-2015December 3, 2014Des Plaines, IL
Toshiba American Medical Systems Inc
Class IITerminated
Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301A/2D X-ray CT system with a 320-row 0.5...
Reason: Potential problem with the cardiac function analysis software (CFA). Incorrect analysis results may be displayed in the Function Parameters for the Entire Heart displayed as analy...
Z-0472-2015December 3, 2014Tustin, CA
Toshiba American Medical Systems Inc
Class IITerminated
Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301C X-ray CT system with a 320-row 0.5 mm det...
Reason: Potential problem with the cardiac function analysis software (CFA). Incorrect analysis results may be displayed in the Function Parameters for the Entire Heart displayed as analy...
Z-0471-2015December 3, 2014Tustin, CA
Philips Medical Systems (Cleveland) Inc
Class IITerminated
IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal DX/HX/EX Upgrade model number: 881011 IntelliSpace Portal DX/HX/EX Demo model number: 881012 IntelliSpace Portal IX model numbe...
Reason: Software defect. In certain circumstances, the application may display incorrect measurements of cardiac and aortic anatomy used to select and size the Transcatheter heart valve (...
Z-0473-2015December 3, 2014Cleveland, OH
Philips Medical Systems (Cleveland) Inc
Class IITerminated
BrightView product code: 882478 BrightView X product code: 882480 BrightView XCT product code: 882482 and 882454
Reason: Software issues
Z-0450-2015December 3, 2014Cleveland, OH
Nidek Inc
Class IITerminated
Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic Device. The Nidek Multicolor Laser photocoagulator Model MC-500 is indicated for use in retinal photocoagulation f...
Reason: When the MC-500 is turned on and coagulation is performed without changing the laser color, the delivery unit occasionally fails to emit the laser, or the power output is lower tha...
Z-0224-2015November 26, 2014Fremont, CA
Accuray Incorporated
Class IITerminated
CyberKnife Robotic Radiosurgery System with the first generation IRIS Variable Aperture Collimator. The CyberKnife is indicated for treatment planning and image guided stereotactic Radiosurgery and...
Reason: Software upgrade to correct potential safety issue related to CyberKnife System that occurs when upgrading the Treatment Delivery Software for the first generation Iris Variable Ap...
Z-0218-2015November 26, 2014Sunnyvale, CA
Nidek Inc
Class IITerminated
MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases.
Reason: Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory function problem was not reported as required.
Z-0222-2015November 26, 2014Fremont, CA
Maquet Cardiovascular Us Sales, Llc
Class IITerminated
Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide removal system used to pump blood thorough the extracorporeal bypass circuit for circulatory and/or pulmonary support dur...
Reason: Cardiohelp- i System may have a software issue that can potentially result in an erroneous display of a "Battery Needs Service" message after startup of the units when us...
Z-0211-2015November 19, 2014Wayne, NJ
Philips Medical Systems, Inc.
Class IITerminated
Philips Medical Systems Allura Xper FD20C Radiological Imaging with software version R8.2.O; System Code: 722028. The Allura Xper FD series are intended for use on human patients to perform: Vascu...
Reason: Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handling was detected, can result in a hazardous movement of the C-arc. system.
Z-0181-2015November 19, 2014Andover, MA
Philips Medical Systems, Inc.
Class IITerminated
Philips Medical Systems Allura Xper FD20C with software version R8.2.O System Code: 722035. The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular an...
Reason: Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handling was detected, can result in a hazardous movement of the C-arc. system.
Z-0182-2015November 19, 2014Andover, MA
Smiths Medical ASD, Inc.
Class IITerminated
CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01. Product Usage: The CADD-Solis Medication Safety Software- Administrator allows use of a computer to crea...
Reason: Smiths Medical has identified an issue with a single batch (Lot Number 2752712) of CADD"-Solis Medication Safety Software Administrator 3.1 CDs. CADD"-Solis Medicat...
Z-0166-2015November 12, 2014Saint Paul, MN
Iba Dosimetry Gmbh
Class IITerminated
COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological
Reason: Error in the software. A deviation between reconstructed and planned dose distribution may not be detected prior to treatment and this can result in an over or under-estimation of...
Z-0168-2015November 12, 2014Schwarzenbruck, N/A
Nellcor Puritan Bennett Inc. (dba Covidien LP)
Class ITerminated
Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NIC...
Reason: A software issue may lead to ventilator inoperative situations.
Z-0112-2015November 5, 2014Boulder, CO
Philips Medical Systems, Inc.
Class IITerminated
Philips IntelliVue Monitors with software revisions J.21.03, J.21.19. Model Product MP5 M8105A; MP5SC M8105AS; MP5T M8105AT; MP5 Upgrade M8105AU ; MP5SC Upgrade 866327 The monitors a...
Reason: Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NBP automatic measurement series is stopped
Z-0104-2015October 29, 2014Andover, MA
Philips Medical Systems, Inc.
Class IITerminated
Philips Avalon Monitors with software revision J.30.58: Model Product FM20 M2702A ; FM30 M2703A ; FM50 M2705A Intended for: " Monitoring the physiological parameters of pregnant women " ...
Reason: Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NBP automatic measurement series is stopped
Z-0105-2015October 29, 2014Andover, MA
Merge Healthcare, Inc.
Class IITerminated
eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components of a PACS (Picture Archiving and Communications System). Product Usage: eFilm Workstation is a software application t...
Reason: There is an issue related to eFilm Workstation versions 4.0 and 4.0.1 when having multiple studies open and utilizing the thumbnail panel to select multiple series from multiple st...