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    PM 25 V3 U F KP

    FDA UDI
    UTAK LABORATORIES, INC.·B800PM25V3UFKP0·PM 25 V3 U F KP

    BENZODIAZEPINES

    FDA UDI
    UTAK LABORATORIES, INC.·B800BENZUFKP0·BENZODIAZEPINES

    PRECISE TREATMENT TABLE

    FDA Adverse Event
    Malfunction ·ELEKTA LTD·Product code IYE·August 20, 2015

    FENTANYL CALIBRATOR LEVEL 3

    FDA UDI
    UTAK LABORATORIES, INC.·B800FENTCAL3UFKP0·FENTANYL CALIBRATOR LEVEL 3

    FENTANYL CALIBRATOR LEVEL 1

    FDA UDI
    UTAK LABORATORIES, INC.·B800FENTCAL1UFKP0·FENTANYL CALIBRATOR LEVEL 1

    PAIN MANAGEMENT 100 NG/ML

    FDA UDI
    UTAK LABORATORIES, INC.·B800PM100V3UFKP0·PAIN MANAGEMENT 100 NG/ML

    FENTANYL CALIBRATOR LEVEL 5

    FDA UDI
    UTAK LABORATORIES, INC.·B800FENTCAL5UFKP0·FENTANYL CALIBRATOR LEVEL 5

    7-HMG 75 NG/ML

    FDA UDI
    UTAK LABORATORIES, INC.·B8007HMG75UFKP0·7-HMG 75 NG/ML

    FENTANYL CALIBRATOR LEVEL 4

    FDA UDI
    UTAK LABORATORIES, INC.·B800FENTCAL4UFKP0·FENTANYL CALIBRATOR LEVEL 4

    FENTANYL CALIBRATOR LEVEL 2

    FDA UDI
    UTAK LABORATORIES, INC.·B800FENTCAL2UFKP0·FENTANYL CALIBRATOR LEVEL 2

    PRECISE SERIES LINAC

    FDA Adverse Event
    Malfunction ·ELEKTA LTD·Product code IYE·August 11, 2015

    Synergy XVI XVI can incorrectly calculate the target position of the treatment table, because of an error that does not occur very frequently. This is the sequence of events when this error occurs - (1) You do an online VolumeView acquisition and registration. (2) You accept the registration and the Table Move Assistant dialog box appears. (3) The Relative Actual column of the Table Move Assistant dialog box incorrectly appears blank. (4) When this occurs, XVI does not read the Absolute Actual position of the treatment table. This causes XVI to calculate the treatment table moves from the zero position of the treatment table (+0.0, + 0.0, + 0.0). (5) In XVI R5.0, if the Relative Set values are less than or equal to + or -2.5cm (for earlier releases of XVI, the value is + or -2cm), you can do remote automatic table movement (RATM) from the function keypad (FKP). (6) When you press the Table ASU (automatic setup) buttons, the treatment table moves to a position that was incorrectly calculated from XVI.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·February 26, 2014

    Synergy XVI XVI can incorrectly calculate the target position of the treatment table, because of an error that does not occur very frequently. This is the sequence of events when this error occurs - (1) You do an online VolumeView acquisition and registration. (2) You accept the registration and the Table Move Assistant dialog box appears. (3) The Relative Actual column of the Table Move Assistant dialog box incorrectly appears blank. (4) When this occurs, XVI does not read the Absolute Actual position of the treatment table. This causes XVI to calculate the treatment table moves from the zero position of the treatment table (+0.0, + 0.0, + 0.0). (5) In XVI R5.0, if the Relative Set values are less than or equal to + or -2.5cm (for earlier releases of XVI, the value is + or -2cm), you can do remote automatic table movement (RATM) from the function keypad (FKP). (6) When you press the Table ASU (automatic setup) buttons, the treatment table moves to a position that was incorrectly calculated from XVI.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IYE·November 25, 2013

    Synergy XVI The Elekta Synergy S is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IYE·November 25, 2013

    TINA SYSTEM 1000 MACHINE USED - EXCELLENT CONDITION

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - LARGO·Product code FKP·March 17, 2009

    SYSTEM 1000 SPDS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP.·Product code FKP·January 15, 2004

    SYSTEM 1000 SPDS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP.·Product code FKP·February 12, 2004

    SYSTEM 1000 SPDS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKP·March 3, 2004

    SYSTEM 1000 SPDS

    FDA Adverse Event
    Other ·BAXTER HEALTHCARE CORPORATION·Product code FKP·January 15, 2004

    ASAHI APS HEMODIALYZER

    FDA Adverse Event
    Other ·NEXTRON MEDICAL·Product code FKP·March 15, 2004