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    PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    Brilliance 64 Computed Tomography X-Ray System, 510(k) #K033326, Model Number: 728231, Serial Numbers: 9745, 90169, and 95414. The recalled device systems are equipped with Version 3.5 Beta 1 software.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·September 22, 2011

    Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300003, 300004, and 300005. The recalled CT systems are equipped with Software Version 3.5 Beta 2. Product Usage: The Brilliance Big Bore is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·August 29, 2011

    Brilliance 64 CT (Computed Tomography) System, 510 (k) #K033326, Model #728231, Serial Numbers: 4003, 9875, and 90135. The recalled CT systems are equipped with Software Version 3.5 Beta 2. Product Usage: The Brilliance Big Bore is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·August 29, 2011

    Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300005, 300010, 300011, 300012, 300013, 300014, 300015, 300016, 300017, 300018, 300019, 300020 and 300021. Product Usage: The Ingenuity CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·November 11, 2011

    Brilliance 64 Computed Tomography System, Model #728231, 510(k) #K 033326, Serial Numbers: 95504, 91003, 300030, 95130, and 95157. The Brilliance 64 is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·September 6, 2011

    Ingenuity CT computed Tomography System, Model #728326, 510(k) #K 033326, Serial Numbers: 300010 and 300018. The Ingenuity CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·September 6, 2011

    Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300003, 300004, 300005, and 300010. Product Usage: The Ingenuity CT is a Computed Tomography X-Ray System intended to produce cross-asectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·December 8, 2011

    Baltic Denture System BDLoad

    FDA UDI
    Merz Dental GmbH·D7091033326·Baltic Denture System BDLoad BDLoad Mm6 PLSEbi...

    FUNET AMY MAMA BODY THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 34CC, 40CC, DATASCOPE INSERTION KIT FOR 8 FR, POLYIMIDE ALT B

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ADVANTAGE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 3, 2013

    POWER PRO AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code INK·March 22, 2011

    ZENITH AAA ILIAC LEG GRAFT

    FDA Adverse Event
    Injury ·COOK, INC.·Product code MIH·April 23, 2008

    D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·February 27, 2014

    R90 SPACERS

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC.·Product code MQP·October 9, 2009

    BD PHOENIX¿ NMIC-311

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 19, 2026

    BD PHOENIX¿ NMIC-311

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 19, 2026

    R90 SPACERS

    FDA Adverse Event
    Other ·WARSAW ORTHOPEDIC INC·Product code MAX·November 6, 2009

    R90 SPACERS

    FDA Adverse Event
    Injury ·SOFAMOR DANEK DEGGENDORF GMBH·Product code MAX·December 21, 2009