Catalys Precision Laser System-Catalys - U - US product; Catalys-1 - International product; software version 3.00.05 The OptiMedica Catalys Precision Laser System is indicated for use in patients u...
Reason: Software anomaly on OptiMedica CATALYS System version 3.00.05 that may result in incorrect parameters provided for cataract incision surgeon templates and both eyes have the same p...
Z-1683-2015June 3, 2015Sunnyvale, CA
RAYSEARCH LABORATORIES AB
Class IITerminated
RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treat...
Reason: RaySearch Laboratories AB became aware of an issue with the dose calculation for some imported VMAT plans where controls points are defined with wide gantry angle spacing.
Z-1679-2015June 3, 2015Stockholm
Siemens Medical Solutions USA, Inc
Class IITerminated
SIEMENS Uroskop Omnia Max ; a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray diagnostic, endourology and minimal invasive urology/surgery). The...
Reason: Study and all acquired images deleted when using systems with software version VE10E. Acquisitions have to be repeated. Connection with portable detectors (MAX wi-D, MAX mini) is...
Z-1670-2015June 3, 2015Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM Emotion 16, the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane take...
Reason: Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessary to rescan patients. Syngo Main UI may crash if the Patient Browser is scrolled w...
Z-1645-2015June 3, 2015Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM Perspective; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane tak...
Reason: Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessary to rescan patients. Syngo Main UI may crash if the Patient Browser is scrolled w...
Z-1646-2015June 3, 2015Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
SIEMENS Ysio Max; a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, ...
Reason: Study and all acquired images deleted when using systems with software version VE10E. Acquisitions have to be repeated. Connection with portable detectors (MAX wi-D, MAX mini) is...
Z-1667-2015June 3, 2015Malvern, PA
Mindray DS USA, Inc. dba Mindray North America
Class IITerminated
Panorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with Arrhythmia Detection and Alarm. Part number 0998-00-0708-01. The Panorama Network includes the Panorama Telemetry Syst...
Reason: Software anomaly in the Panorama System software version 8.9 that manifests when the Panorama is in use with Mindray Passport V Monitor. Arrhythmia alarms which were previously di...
Z-1675-2015June 3, 2015Mahwah, NJ
Siemens Medical Solutions USA, Inc
Class IITerminated
SIEMENS Axiom Luminos dRF Max, a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general ...
Reason: Study and all acquired images deleted when using systems with software version VE10E. Acquisitions have to be repeated. Connection with portable detectors (MAX wi-D, MAX mini) is...
Z-1668-2015June 3, 2015Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
SIEMENS Luminos Agile Max; a universal imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat detector, it can perform a range of applications i...
Reason: Study and all acquired images deleted when using systems with software version VE10E. Acquisitions have to be repeated. Connection with portable detectors (MAX wi-D, MAX mini) is...
Z-1669-2015June 3, 2015Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM Emotion 6; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken...
Reason: Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessary to rescan patients. Syngo Main UI may crash if the Patient Browser is scrolled w...
Z-1644-2015June 3, 2015Malvern, PA
bioMerieux, Inc.
Class IITerminated
MYLA server HP Proliant: DL380-G8 and ML350-G6 version 3.xx computer application software. MYLA V3 is a computer application ("Middleware") based on Web 2.0 technology which: Interfaces between the...
Reason: The MYLA¿ server could slow down due to the volume ( weight ) of the data to manage and it could also stop processing, impacting the server start-up phase. The problem occurs in ...
Z-1621-2015May 27, 2015Durham, NC
Philips Medical Systems, Inc.
Class IITerminated
Pinnacle3 Software Version 10.0, Model 459800200841. Product Usage: The Pinnacle 3 RTP software allows qualified medical professionals to enter patient data into the system, use that data to cons...
Reason: A problem (the dose computed in planning mode is calculated incorrectly ) has been detected in the Philips Pinnacle3 software version 10.0 that, if it were to re-occur, could pose ...
Z-1643-2015May 27, 2015Andover, MA
Baxter Corporation Englewood
Class IITerminated
ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition) Product Usage: The ABACUS Software is a Windows-based order entry software application for comprehensive total pare...
Reason: Baxter Corporation is conducting a field action for the ABACUS SE and ME models due to the possibility that the compounder will load the incorrect formula upon scanning the bag lab...
Z-1628-2015May 27, 2015Englewood, CO
Fujifilm Medical Systems U.S.A., Inc.
Class IITerminated
FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Archiving and Communication System Software versions: Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1
Reason: Measurement values in the EMR may not accurately reflect the actual measurement value on the Synapse Cardiovascular clinical report.
Z-1611-2015May 20, 2015Stamford, CT
Brainlab AG
Class IITerminated
ExacTrac 6.x. is software used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures.
Reason: ExacTrac 6.x Patient Positioning System: Potentially incorrect patient positioning when using the ExacTrac Cone Beam CT (CBCT) with a CBCT acquired at a couch angle other than 0.0 ...
Z-1582-2015May 13, 2015Feldkirchen, N/A
Viewray Incorporated
Class IITerminated
ViewRay System, Radiation Therapy System
Reason: The software was not correctly using the RT (Radiation Therapy) to MR (Magnetic Resonance image) coordinate correction for non HFS (Head First Supine) patient orientations, resulti...
Z-1580-2015May 13, 2015Oakwood Village, OH
MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
Class IITerminated
MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)
Reason: The operator console allows users to deliver therapeutic radiation to patients even though a specific communication error relevant to imaging conditions has occurred. In addition, ...
Z-1574-2015May 13, 2015HIROSHIMA, N/A
Stryker Instruments Div. of Stryker Corporation
Class IIITerminated
Universal Charger Product Usage: The Stryker Universal Battery Charger is designed to be used in conjunction with and provide power to non-sterile and sterile batteries. The Stryker Universal...
Reason: The Stryker Universal Battery Charger is not transmitting usage data to the Stryker Cloud as designed. The firm is initiating a software correction to address the issue.
Z-1587-2015May 13, 2015Portage, MI
Siemens Medical Solutions USA, Inc.
Class IITerminated
ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model number 10433816. The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and...
Reason: In certain situations, loss of post exercise images can occur in Stress Echo.
Z-1584-2015May 13, 2015Mountain View, CA
Siemens Medical Solutions USA, Inc.
Class IITerminated
ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, VA16D and VA16E. Model 10433816. Product Usage: The SC2000 ultrasound imaging system is intended for the following appli...
Reason: In some cases, the system is unable to capture a clip or image during a routine scan.
Z-1581-2015May 13, 2015Mountain View, CA
Nihon Kohden America Inc
Class IITerminated
Remote Network Station, Catalog RNS-9703, Model No. RNS-9703-19, RNS-9703-24, Software version 02.40. The RNS 9703 is intended for use by medical professionals to provide secondary cardiac and vita...
Reason: Nihon Kohden America (NKA) is recalling the Remote Network Station (RNS) 9703 because it may fail to sound.
Z-1543-2015May 6, 2015Irvine, CA
Lumenis Limited
Class IITerminated
Light Sheer Desire Diode Laser System with XC Handpiece Accessory options.
Reason: Device software treatment preset parameters for the XC treatment handpiece do not match the Operator Manual, and exceed recommended settings. Operator Manual parameters are lower t...
Z-1519-2015May 6, 2015Yokneam
Dako North America Inc.
Class IITerminated
Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the Dako Omnis System, an automated slide stainer for in vitro diagnostic use. The TRD is intended to distribute patie...
Reason: If a user requests slides from the LIS or TPID, then updates a request by changing the test, the TRD software will reject the update. The LIS and printed slide label will display t...
Z-1548-2015May 6, 2015Carpinteria, CA
Ortho-Clinical Diagnostics
Class IITerminated
Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems, Catalog Number 6801375, Global Trade Item Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890...
Reason: Software Anomaly; It is possible for the device to process samples with a cartridge other than the intended cartridge, potentially leading to erroneous patient results. If this ano...
Z-1521-2015May 6, 2015Rochester, NY
Steris Corporation
Class IITerminated
AMSCO C and AMSCO 400 Steam Sterilizers, STERIS Corporation. AMSCO C Small Sterilizer, AMSCO 400 Small Sterilizer, AMSCO 400 Medium Sterilizer. Designed for sterilization of heat and moisture-st...
Reason: STERIS has identified that the control board software in select AMSCO 400 and AMSCO C units will interrupt and cancel a processing cycle should the selected sterilizer shutdown tim...