BEUDAMED
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    LANTIS oncology Information System, an accessory to the Linear Accelerator, as part of the COHERENCE RT Therapist, but also cleared under the ONCOR Avante-Garde and Expression, as well as the syngo RT Therapist system, as part of the ARTISTE And PRIMUS system. Manufactured by IMPAC Medical Inc., Sunnyvale, CA, device distributed by Siemens Medical Solutions Oncology Care System, Concord, CA Electronic record management system as part of a linear accelerator system used to keep track of notes and database for oncology electronic medical records.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·August 21, 2009

    MAMMOTOME REVOLVE CONTROL MODULE

    FDA Adverse Event
    Malfunction ·DEVICOR MEDICAL PRODUCTS, INC.·Product code KNW·September 24, 2018

    SC6002

    FDA Adverse Event
    Malfunction ·DRAGER MEDICAL SYSTEMS, INC. (IT/M)·Product code DRT·December 14, 2007

    ENDOWRIST ONE VESSEL SEALER

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·June 24, 2015

    640G INSULIN PUMP MMT-1711K

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·September 3, 2020

    UNKNOWN

    FDA Adverse Event
    Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·July 7, 2022

    PUMP MMT-1782KL 670G MM RPL

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·March 18, 2021

    PUMP MMT-1714K 630G BLACK MMOL CANADA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·February 11, 2019

    PANORAMA CENTRAL STATION WITH TELEMETRY

    FDA Adverse Event
    Death ·SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD·Product code MHX·March 15, 2016

    670G INSULIN PUMP MMT-1780KL

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·July 22, 2021

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·August 12, 2021

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·August 17, 2021

    PUMP MMT-1782K 670G V4.11 MM

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·October 31, 2023

    INPEN MMT-105ELGYNA ELI LILY GRAY

    FDA Adverse Event
    Malfunction ·COMPANION MEDICAL INC·Product code FMF·June 13, 2023

    PUMP MMT-1712KL 640G V4.10 BK SF MG

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 5, 2023

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·June 7, 2022

    MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·February 7, 2022

    670G INSULIN PUMP MMT-1780KL

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·July 28, 2022

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·August 30, 2022

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·July 26, 2022