SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE AG...
Reason: Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the...
Z-1036-2013April 10, 2013Martinez, CA
Siemens Medical Solutions USA, Inc
Class IITerminated
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: Primeview 3i...
Reason: Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the...
Z-1044-2013April 10, 2013Martinez, CA
Siemens Medical Solutions USA, Inc
Class IITerminated
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: Primeview 3i...
Reason: Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the...
Z-1042-2013April 10, 2013Martinez, CA
Zyno Medical LLC
Class IITerminated
Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human patient.
Reason: Update Instruction For Use for Preventative Maintenance (PM) Schedule and addition of Odometer software to monitor accumulative fluid volume infused by the pump
Z-1024-2013April 10, 2013Natick, MA
Siemens Medical Solutions USA, Inc
Class IITerminated
Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Angiographic x-ray system
Reason: The firm has become aware of a potential issue on Artis systems with the software Artis VC20x/VC21A/VD10x that have a DSA license installed. Under certain preconditions, executing...
Z-0997-2013April 3, 2013Malvern, PA
Vital Images, Inc.
Class IITerminated
Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3 The software is a medical diagnostic system that allow...
Reason: Vital Images has found a potential error in measurement generated through the software which affects all versions of Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (V...
Z-1002-2013April 3, 2013Minnetonka, MN
Siemens Medical Solutions USA, Inc
Class IITerminated
Siemens Axiom Artis zeego systems with software version VC14, VC20 and VC21 in conjunction with specific technical configuration Angiographic x-ray system
Reason: In the course of the firm's product monitoring activities, a potential risk for patient or operators was determined during the operation of an Artis zeego system with software revi...
Z-0992-2013April 3, 2013Malvern, PA
Toshiba American Medical Systems Inc
Class IITerminated
Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures.
Reason: Lost and incorrect images. When using the "F-Rec" fluoroscopy image acquisition recording option in the "manual mode" an infrequent software error may cause images from another stu...
Z-0994-2013April 3, 2013Tustin, CA
Siemens Medical Solutions USA, Inc
Class IITerminated
Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system.
Reason: Sporadic hang-up malfunctions concerning 3D reconstructions during activated "Preview Image" functionality.
Z-0948-2013March 20, 2013Malvern, PA
Hill-Rom, Inc.
Class IITerminated
TotalCare SpO2RT2 bed. Product Usage: Bed, flotation therapy, powered bed may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/prog...
Reason: In certain situations a software problem with the TotalCare SpO2RT¿ 2 bed may occur that can lead to inadvertent loss of sufficient surface cushion pressure to adequately support...
Z-0949-2013March 20, 2013Batesville, IN
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the b...
Reason: This field change order is being released to update software and customer release notes to the affected installed base.
Z-0950-2013March 20, 2013Cleveland, OH
Siemens Medical Solutions USA, Inc
Class IITerminated
SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No. 08162815, Digital linear accelerators, MOSAIQ OIS system, Distributed by SIEMENS Healthcare IM CR RO, CR Radiation O...
Reason: Siemens became aware of a potential safety issue when using the "In-session resumption" feature of the syngo RT Therapist (RTT) 4.3 software. The RTT will send again the previously...
Z-0907-2013March 13, 2013Concord, CA
Beckman Coulter Inc.
Class IITerminated
Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium.
Reason: Due to a software data storage limitation which only occurs under certain conditions, measurements of the Reagent Blank (RB) or Calibration (CAL) sample results are not saved and t...
Z-0913-2013March 13, 2013Brea, CA
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomography X-Ray System. The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is...
Reason: Incorrect values may be displayed. Philips is issuing a software update (version 4.5.5) to the Extended Brilliance Workspace (EBW) systems currently running software version(s) 4....
Z-0906-2013March 13, 2013Cleveland, OH
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Philips Medical Systems, GEMINI LXL - Model #882412; GEMINI TF 16 - Model #882470 and Model #882473; GEMINI TF 64 - Model #882471, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT)...
Reason: Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to generate Intensity Projection data s...
Z-0882-2013March 6, 2013Cleveland, OH
Philips Healthcare Inc.
Class IITerminated
Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020, 712022, and 712082 Product Usage: Digital radiographic system
Reason: When the operator for a wall stand view selects an "image rotation" different from default, or such image rotation is preset in the examination database, then the resulting image m...
Z-0884-2013March 6, 2013Andover, MA
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260. A component of the Computed Tomography X-Ray System.
Reason: Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to generate Intensity Projection data s...
Z-0881-2013March 6, 2013Cleveland, OH
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Philips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore, Model #728243; and Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore Oncology, Model #728244.
Reason: Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to generate Intensity Projection data s...
Z-0880-2013March 6, 2013Cleveland, OH
GE Healthcare, LLC
Class IITerminated
GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System
Reason: GE Healthcare has become aware of a software issue on the interface of the Brivo XR385 DR-F/ Model 5271997 radiographic product related to Visual indication as mandated by the US C...
Z-0761-2013March 6, 2013Waukesha, WI
Intel-GE Care Innovations LLC
Class IITerminated
QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents' movements.
Reason: Care Innovations detected a software anomaly: During the engineering investigation into the cause of why a Wander Alert was not generated, a defect in the implementation of the Wan...
Z-0877-2013March 6, 2013Roseville, CA
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Philips Medical Systems, GEMINI TF Big Bore, Model #882476, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning system, a diagnostic imaging systems for fixed or mobile inst...
Reason: Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to generate Intensity Projection data s...
Z-0883-2013March 6, 2013Cleveland, OH
Mindray DS USA, Inc. d.b.a. Mindray North America
Class IITerminated
Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA00003 (DPM Central Monitoring System) 115-006908-01, -03, -04 (DPM software upgra...
Reason: Mindray has identified a software anomaly that may where, in the presence of an asystole, the Telepack ECG waveform may produce a unique step pattern (instead of a flat line) if Le...
Reason: Inaccurate readings. Software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations. The accuracy on a...
Z-0802-2013February 20, 2013Ann Arbor, MI
Hamilton Medical Inc
Class ITerminated
HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON T-1 Ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics
Reason: Analysis of a customer complaint has shown that during ventilation of small pediatric patients with high airway resistance and low lung compliance, the oxygen consumption of a Hami...
Z-0741-2013February 6, 2013Reno, NV
Roche Molecular Systems, Inc.
Class IITerminated
COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE.
Reason: The COBAS TaqMan MTB Test Definition Files (TDF) v3.0, for both CE-IVD and JPN-IVD tests, being used with AMPLILINK software version 3.3 series and COBAS TaqMan MTB Test Kits, both...