syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition Edge-Model #10590000; SOMATOM Definition AS Model #8098027; SOMATOM Definition Flash Mo...
Reason: SOMATOM Definition Edge, SOMATOM Definition AS, SOMATOM Definition Flash with software syngo.CT with Software version VA48A_SP5 may result in scanning workflow interruptions and u...
Z-2440-2019September 11, 2019Malvern, PA
Haag-Streit USA Inc
Class IITerminated
HS Hi-R NEO 900 Reference # 657 820 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible through the modular construction and the diversity of the equipment...
Reason: software error in the central control unit of the floor stand.
Z-2482-2019September 11, 2019Mason, OH
Abbott Gmbh & Co. KG
Class IITerminated
Alinity ci -series System Control¿Module, Part Number 03R70 01 Product Usage: The Alinity ci series System Control Module has a scalable design to provide full integration of clinical chemistry a...
Reason: Abbott has identified an issue with all on market versions (v2.6.0 and v2.6.1) of Alinity ci series Software where incorrect results may occur after a system Stop due to the Alinit...
Z-2363-2019September 4, 2019Wiesbaden, N/A
Agilent Technologies, Inc.
Class IITerminated
MassHunter Quantitative Analysis Software, Version B.07.01, used with Triple Quadrupole Mass Spectrometers, models K6460 and K6420 Product Usage: A mass spectrometer for clinical use is a device...
Reason: When utilizing specific software versions of an LC/MS device, and Batch at a Glance in Compound Table view, a defect occurs when a new sample(s) is inserted. This defect creates a ...
Z-2359-2019September 4, 2019Santa Clara, CA
Phadia Ab
Class IITerminated
Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including software for immunodiagnostic testing. The instrument is designed to handle al...
Reason: code 7-102 Liquid Sensor Error
Z-2397-2019September 4, 2019Uppsala, N/A
Siemens Medical Solutions USA, Inc.
Class IIOngoing
ACUSON NX3 Elite Diagnostic Ultrasound System, Model # 11235411, RX Only, Siemens Medical Solutions, containing software versions: VA10A, VA10B, VA10C, VA10D, VA10E, VA10F, VB20A, and VB20B; UDI ...
Reason: The action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined . The transit voltage ...
Z-2353-2019August 28, 2019Mountain View, CA
Luminex Corporation
Class IITerminated
Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner Label/Labeling: JADAK JDK-2330 REV B 170512-017
Reason: An incorrect control board and firmware installed in some of the Hand Held Barcode Scanners could result in sample/patient mismatch or duplicate results (from other patients specim...
Z-2292-2019August 28, 2019Austin, TX
Siemens Medical Solutions USA, Inc.
Class IIOngoing
ACUSON NX3 Diagnostic Ultrasound System, Model # 11235612, RX Only, Siemens Medical Solutions, containing software versions: VA10A, VA10B, VA10C, VA10D, VA10E, VA10F, VB20A, and VB20B; UDI # 0405...
Reason: The action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined . The transit voltage ...
Z-2352-2019August 28, 2019Mountain View, CA
Qiagen Sciences LLC
Class IIOngoing
QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (The QIAsymphony SP instrument is designed to perform automated purification of nucleic acids-IVD) Model Number: 9001297 ...
Reason: QIAsymphony software version 5.0.3 - Software issue incorreclty assigns the 2D bar code eluate ID to the sample within the results file. If 2D bar code eluate IDs are not checked ...
Z-2319-2019August 28, 2019Germantown, MD
Siemens Medical Solutions USA, Inc.
Class IIOngoing
ACUSON NX2 Diagnostic Ultrasound System, Model # 11284381, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869030005 The ACUSON NX2 diagnost...
Reason: The action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined . The transit voltage ...
Z-2350-2019August 28, 2019Mountain View, CA
Siemens Medical Solutions USA, Inc.
Class IIOngoing
ACUSON NX2 Elite Diagnostic Ultrasound System, Model # 11284500, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869050775 The ACUSON NX2 dia...
Reason: The action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined . The transit voltage ...
Z-2351-2019August 28, 2019Mountain View, CA
Radiometer America Inc
Class IITerminated
ABL90 FLEX Analyzer REF 393090 UDI:05700693930909
Reason: Software Security; The action is being initiated because of software security vulnerabilities with the firm's analyzer operating system, which may cause the device to shutdown o...
Z-2320-2019August 28, 2019Brea, CA
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM Drive, Model Number 10431700 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission d...
Reason: Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
Z-2271-2019August 21, 2019Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM Force, Model Number 10742326 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission d...
Reason: Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
Z-2274-2019August 21, 2019Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM Definition Edge, Model Number 10590000 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray tran...
Reason: Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
Z-2269-2019August 21, 2019Malvern, PA
Elekta, Inc.
Class IITerminated
iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2
Reason: Potential for iGUIDE to incorrectly monitor the 3D position.
Z-2230-2019August 21, 2019Atlanta, GA
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM Definition Flash, Model Number 10430603 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray tra...
Reason: Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
Z-2270-2019August 21, 2019Malvern, PA
Fenwal Inc
Class ITerminated
VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product Usage: The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcar...
Reason: The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm priority in Software versions 1.7 and 1.9a of Volumat MC Agilia Software and versions ...
Z-2064-2019August 21, 2019Lake Zurich, IL
Fenwal Inc
Class ITerminated
Vigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1 Product Usage: Vigilant Drug Lib is Dose Error Reduction Software that, when used in combination with Volumat MC Agilia infus...
Reason: The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm priority in Software versions 1.7 and 1.9a of Volumat MC Agilia Software and versions ...
Z-2065-2019August 21, 2019Lake Zurich, IL
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM Definition AS, Model Number 8098027 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmi...
Reason: Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
Z-2268-2019August 21, 2019Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM Edge Plus, Model Number 10267000 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmissi...
Reason: Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
Z-2273-2019August 21, 2019Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM Confidence, Model Number 10590100 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmiss...
Reason: Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
Z-2272-2019August 21, 2019Malvern, PA
Philips North America, LLC
Class IITerminated
Philips Azurion systems with software version R1.2 -Interventional Fluoroscopic X-ray system as follows: Azurion 3 M12, Azurion 3 M15, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20 M...
Reason: The cold restart of Azurion R1.2 systems may take up to 7 minutes if the system is connected to the mains power supply for more than 50 days, may result in a delay of treatment.