EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical System IS3000. The Endo Wrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si Su...
Reason: Intuitive Surgical is initiating a voluntary correction relating to the labeling and software associated with the EndoWrist. One Vessel Sealer for the da Vinci Si (IS3000) Surgical...
Z-0063-2015October 22, 2014Sunnyvale, CA
Ortho-Clinical Diagnostics
Class IITerminated
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code 6802445. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a va...
Reason: Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the VITROS 4600 Chemistry Systems and VITROS Integrated Systems. Internal testing con...
Z-0077-2015October 22, 2014Rochester, NY
Ortho-Clinical Diagnostics
Class IITerminated
VITROS 5600 Integrated System, System Product Code 6802413. For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using...
Reason: Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the VITROS 4600 Chemistry Systems and VITROS Integrated Systems. Internal testing con...
Z-0078-2015October 22, 2014Rochester, NY
Mckesson Information Solutions LLC
Class IITerminated
McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
Reason: Software Error: The McKesson Cardiology Hemo calculation section incorrectly converts the Hemoglobin value before it is utilized in the applicable formula calculations.
Z-0042-2015October 15, 2014Alpharetta, GA
Siemens Medical Solutions USA, Inc
Class IITerminated
Artis zee and Artis zeego systems. x-ray, angiographic system
Reason: There is a potential problem with Artis zee and Artis zeego systems running software version VC21B and being used in conjunction with the Large Display, in that under certain circu...
Z-2569-2014October 1, 2014Malvern, PA
Dako North America Inc.
Class IITerminated
Dako Autostainer Link 48 with software version Dako Link 4.0.3, Model No. AS480 Product Usage: For in vitro diagnostic use. The Dako Autostainer Link 48 is an automated slide processing system com...
Reason: Dako is recalling the Dako Link 4.0.3 software on the Dako Autostainer Link 48 because Dako has determined that an upgrade to this version of the software may cause premature rejec...
Z-2708-2014October 1, 2014Carpinteria, CA
Siemens Medical Solutions USA, Inc
Class IITerminated
The Ysio Systems with software version VC10 The Ysio enables radiographic and tomographic exposures of the whole Body including: skull, chest, abdomen, and extremities and may be used on pediatric,...
Reason: Siemens discovered that an unlikely error may occur on the Ysio system with fixed detector in the wall stand. This error may result in line artifacts in the image. If these artifa...
Z-2680-2014October 1, 2014Malvern, PA
Philips Medical Systems (Cleveland) Inc
Class IITerminated
The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different...
Reason: During a Field Test (a customer external evaluation period), the customer detected a problem in the CIRS 4.0 Beta 2 software. When using the CIRS 4.0 Beta 2 software, during the r...
Z-2664-2014September 24, 2014Cleveland, OH
Siemens Healthcare Diagnostics, Inc.
Class IITerminated
Siemens CentraLink Data Management System, software version 14. The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation ...
Reason: Siemens Healthcare Diagnostics has identified a task scheduler issue with the CentraLink" Data Management System, software version 14. The issue may cause the software to sto...
Z-2665-2014September 24, 2014Newark, DE
Data Innovations, LLC
Class IITerminated
ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JResultNet is a stand-alone software package that provides connectivity between in-vitro diagnostic instruments (IVDs) and La...
Reason: Potential issues with the ProVue driver have been identified which may cause data to be misassociated with patient results under a given set of circumstances.
Z-2637-2014September 24, 2014Fort Myers, FL
MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
Class IITerminated
VERO Linear Accelerator System, Model Number MHI-TM2000; Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and cond...
Reason: Software Anomaly: If a user changes the calendar setting from Workday to Holiday or vice versa, that would erroneously change the status of treatment/fractions, which are completed...
Z-2653-2014September 24, 2014HIROSHIMA, N/A
Biofire Defense
Class IIITerminated
JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument is a portable thermocycler and real-time fluorimeter capable of simultaneous and rapid identification of multiple biologica...
Reason: BioFire Defense, LLC is initiating a field action for JBAIDS Software version 3.5.0.72 because the wrong version software may have been installed.
Z-2644-2014September 24, 2014Salt Lake City, UT
Illumina Inc
Class IITerminated
Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform. Product Usage: The Illumina MiSeqDx is a sequencing instrument that measures fluorescence signals of la...
Reason: A software component of the MiSeqDx instrument, called the Illumina Worklist Manager (IWM) v1.0.15, fails to perform as intended
Z-2611-2014September 17, 2014San Diego, CA
Siemens Medical Solutions USA, Inc
Class IITerminated
Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies.
Reason: It was discovered that during a RAD examination using Siemens Luminos dRF, Ysio or Uroskop Omnia systems with software version VB10C to VB10F and automatic exposure control, a high...
Z-2292-2014September 17, 2014Malvern, PA
Ab Sciex
Class IITerminated
AB SCIEX API 3200MD" LC/MS/MS System with software: MultiQuantMD 3.0In vitro diagnostic to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens Part Number 5...
Reason: Software- AB SCIEX API 3200MD LC/MS/MS SYSTEM with MultiQuantMD 3.0 software may provide incorrect data for patient diagnosis
Z-2609-2014September 17, 2014Framingham, MA
TomoTherapy Incorporated
Class IITerminated
TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 2.0.0 and 2.0.1 (Hi-Art¿ 5.0.0 and 5.0.1). The TomoTherapy treatment system is intended to be used...
Reason: Accuray is voluntarily recalling TomoTherapy H Series software versions 2.0.0 and 2.0.1 (Hi-Art¿ 5.0.0 and 5.0.1). Accuray has identified potential safety issues (anomalies) with ...
Z-2240-2014August 27, 2014Madison, WI
Ansar Group, Inc. Dba Ansar Medical Technologies, Inc
Class IITerminated
Blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system. The ANX 3.0 system is comprised of these components. 1. Patient Physiological Monitor, 2. Laptop Computer, 3. Stand w/whe...
Reason: The blood pressure (BP) circuit occasionally fails to inflate the blood pressure cuff and the BP circuit fails to activate, resulting in no BP measured.
Z-2268-2014August 27, 2014Philadelphia, PA
Philips Medical Systems, Inc.
Class IITerminated
Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System. Model No. 860426
Reason: Philips IntelliSpace ECG (IECG) Management Systems that are importing Stress ECG records from a Quinton Stress ECG system have the potential for the patient record to contain multi...
Z-2535-2014August 27, 2014Andover, MA
Biolase Technology Inc
Class IITerminated
WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade Kit, Part No. 6201463.
Reason: Biolase is recalling the WaterLase iPlus Dental Laser System because of a discrepancy present in the user interface software (version 1.7). If an error occurs in the procedure scr...
Z-2263-2014August 27, 2014Irvine, CA
Intelerad Medical Systems
Class IITerminated
IntelePACS software versions 3-8-1 to 4-9-1, Product Usage: IntelePACS is a device that receives digital images and data from various sources (such as, CT scanners, MRI scanners, ultrasound syste...
Reason: In specific situation a partially truncated file may be written to the IntelePACS server. This partially truncated file still can be viewed by InteleViewer and InteleViewer will r...
Z-2267-2014August 27, 2014Montreal
Philips Healthcare Informatics, Inc.
Class IITerminated
Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.
Reason: A problem was detected in the Philips IntelliSpace PAC 4.4 software where if patient information is changed in the DICOM header and the study is exported before the image is updat...
Z-2252-2014August 27, 2014Foster City, CA
TomoTherapy Incorporated
Class IITerminated
TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 1.2.0, 1.2.1 and 1.2.2 (Hi-Art¿ 4.2.0, 4.2.1 and 4.2.2). .
Reason: Accuray is voluntarily recalling TomoTherapy H Series software versions 1.2.0, 1.2.1 and 1.2.2 (Hi-Art¿ 4.2.0, 4.2.1 and 4.2.2). Accuray has identified potential safety issues (...
Z-2239-2014August 27, 2014Madison, WI
Nellcor Puritan Bennett Inc. (dba Covidien LP)
Class IITerminated
Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virtual P...
Reason: Covidien is conducting a field correction of the Vital Sync Virtual Patient Monitoring Platform and Informatics Manager due to a mismatch between the alarm priority on the medical ...
Z-2234-2014August 20, 2014Boulder, CO
Siemens Medical Solutions USA, Inc
Class IITerminated
Siemens Syngo RT Therapist and Syngo RT Oncologist intended use of the SIEMENS branded Syngo RT Therapist and Syngo RT Oncologist software applications used with SIEMENS family of linear accelerator s...
Reason: Siemens became aware of a potential issue with the syngo RT Therapist 4.3.SP1 and syngo RT Oncologist 4.3SP1 software applications running on Siemens brand LINAC systems that may e...
Z-2180-2014August 20, 2014Malvern, PA
Brainlab AG
Class IITerminated
Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a pas...
Reason: Brainlab Navigation Software Spine & Trauma 3D 2.0/2.1 offers automatic registration of intraoperatively acquired CT image data sets. To enable automatic registration, the soft...