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Sources: EU EUDAMED, US FDA
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Horizon Medical Imaging system. Product Usage: Horizon Medical Imaging is a medical image and information management application that is intended to receive, transmit store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical image systems. The medical modalities of these medical imaging systems include, but are not limited to, all modalities supported by ACR/NEMA DICOM 3.0 (specifically including mammographic images). Horizon Medical Imaging is intended to function with a variety of storage systems and printers via DICOM and other computer industry standard interfaces and protocols. Horizon Medical Imaging is indicated for use by trained medical professionals including, but not limited to, radiologist, physicians, and medical technologists. Horizon Medical Imaging is also indicated for use in soft copy diagnostic interpretation of medical images and video by physicians trained in such practice (specifically including soft copy diagnostic interpretation of mammographic images).
FDA Enforcement
Class II
·Terminated·Mckesson Medical Imaging Group·August 29, 2012
Mammomat Inspiration system: Product Usage: mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 17, 2014
Mammomat Inspiration system: Product Usage: mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code MUE·October 28, 2014
Siemens Mammomat Inspiration mammography systems. The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·October 29, 2014
Siemens Mammomat Inspiration mammography systems. The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code MUE·September 18, 2014
Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·February 8, 2017
Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code MUE·January 11, 2017
Horizon Medical Imaging system. Product Usage: Horizon Medical Imaging is a medical image and information management application that is intended to receive, transmit store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical image systems. The medical modalities of these medical imaging systems include, but are not limited to, all modalities supported by ACR/NEMA DICOM 3.0 (specifically including mammographic images). Horizon Medical Imaging is intended to function with a variety of storage systems and printers via DICOM and other computer industry standard interfaces and protocols. Horizon Medical Imaging is indicated for use by trained medical professionals including, but not limited to, radiologist, physicians, and medical technologists. Horizon Medical Imaging is also indicated for use in soft copy diagnostic interpretation of medical images and video by physicians trained in such practice (specifically including soft copy diagnostic interpretation of mammographic images).
FDA Recall
Terminated
·Mckesson Medical Imaging Group 10711 Cambie Rdsuite 130 Richmond Canada British Columbia·Product code LLZ·May 29, 2012
Drystar AXYS, Hardcopy Printer A free standing device used to print diagnostic conventional and mammography images on transparent film for viewing on a standard view box. It may be used in any situation in which a hard copy of an image generated by a medical imaging device is required or desirable.
FDA Recall
Terminated
·AGFA Corp.·Product code LMC·May 16, 2008
Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer, Model 4500. For use with Algovita Spinal Cord Stimulation Systems. The version of the software in the Clinician Programmer is v1.1.5. The Algovita Spinal Cord Stimulation system consists of a stimulator (EPG or IPG) that is physically and electrically connected to one or more leads inserted into the patient¿¿"s spinal epidural space. The lead delivers electrical stimulation originating at the stimulator with the purpose of blocking pain signals going to the patient¿¿"s brain. The stimulators are rechargeable, and the frequency of recharging is dependent on individual patient¿¿"s use of the system. The Clinician Programmer (CP) is a hand-held, touch screen device used to create and adjust stimulation parameters that are developed to optimize the therapy for each patient. The CP communicates with the stimulator via the Medical Implant Communication Service (MICS). The CP wirelessly transfers the stimulation parameters to the stimulator. In most clinical settings, the CP can be used by the Health Care Professional to program multiple patient EPGs and IPGs
FDA Enforcement
Class II
·Terminated·Nuvectra·May 11, 2016
LANTIS software with MedOnc Module; MedOnc module is an option of the LANTIS radiotherapy treatment planning software distributed as a component of the firm''s linear accelerator used to deliver radiation therapy to cancer patients. The MedOnc module is distributed by Siemens Medical Solutions USA Oncology Division, 4040 Nelson Avenue, Concord, CA 94520 with their linear accelerators software package called LANTIS. The MedOnc module option is distributed with all LANTIS software copies, but the module must be turned on by an electronic key that is purchased by individual hospitals. Siemens Medical Solutions USA purchases the LANTIS software (code) from IMPAC Medical Systems, Inc., 100 West Evelyn Avenue, Mountain View, CA 94041 (REG#2950347, FEI: 1000123805). IMPAC distributes the same software under the name SEQUENCER.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IYE·January 6, 2005
EasyVision RAD - Radiological Image Processor, software versions: SW R4 2V2L2, SW R4 2V2L3, SW R4 2V2L4, SW R4 2V2L5, SW R4 2V2L6, and SW R4 2V2L7. The EasyVision RAD consists of a computer with digital interfaces, one or two (optional) monitors with keyboard and mouse, and software. The viewing, analysis, processing and printing functions are sent to the EasyVision by means of PMSNet (Philips Medical Systems communication protocol). The main image source for the PCR (Philips Computed Radiography) system is the CR-Reader. Remote database access and image transfer functions are implemented using the DICOM Query/Retrieve and Storage services. The EasyVision RAD provides the following features: receives images sent to it by remote applications (e.g. workstations or imaging modalities) and stores them in a local database; allows the operator to copy images from the local database to remote databases and vice versa; allows a remote system to query the EasyVision local database and to retrieve images from it; allows the operator to view, analyze, process and print the images stored in the local database. Operator may print images stored in the database on a DICOM printer, and is able to read and write DICOM CD-R disks. The device allows processing of and access to the stored raw data so that an image can be post-processed using different image processing algorithms.
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code LLZ·March 10, 2008
MEVATRON KD-2,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), MODEL NUMBERS: 8515520 and 9822685, MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord, CA 94520
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IYE·March 22, 2007
MEVATRON MDX-2,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 9401746,MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord, CA 94520
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IYE·March 22, 2007
MEVATRON KDS-2,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBERS: 9411588 and 9822693,MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord, CA 94520
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IYE·March 22, 2007
MEVATRON MD-2,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 9401654,MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord, CA 94520
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IYE·March 22, 2007
Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toe SKU: CH-STD-KT
FDA Recall
Terminated
·Nextremity Solutions·Product code HWC·January 13, 2022
Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes SKU: CH-MINI-KT
FDA Recall
Terminated
·Nextremity Solutions·Product code HWC·January 13, 2022
Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001. Indicated for the treatment of unresectable metastatic liver tumors.
FDA Recall
Terminated
·Product code NAW·February 27, 2013
Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100
FDA Recall
Terminated
·Medela Inc·Product code FMF·December 5, 2018