BEUDAMED
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    BrightView XCT Gamma Camera, 3/8". Philips Medical Systems, Inc. Intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel.

    FDA Recall
    Terminated ·Philips Medical Systems·Product code KPS·June 15, 2011

    BrightView XCT Gamma Camera, 3/4". Philips Medical Systems, Inc. Intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel.

    FDA Recall
    Terminated ·Philips Medical Systems·Product code KPS·June 15, 2011

    BrightView X Gamma Camera, 3/8". Philips Medical Systems, Inc. Intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel.

    FDA Recall
    Terminated ·Philips Medical Systems·Product code KPS·June 15, 2011

    Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 23, 2014

    Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc., Fitchburg, WI. Pinnacle3 Radiation Therapy Planning System is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes. Pinnacle3 Radiation Therapy Planning System assists the clinician in formulating a treatment plan that maximizes the dose to the treatment volume while minimizing the dose to the surrounding normal tissues. The system is capable of operating in both the forward planning and inverse planning modes. The device is indicated for use in patients deemed to be acceptable candidates for radiation treatment in the judgment of the clinician responsible for patient care. Plans generated using this system are used in the determination of the course of a patient's radiation treatment. They are to be evaluated, modified and implemented by qualified medical personnel.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland), Inc.·November 14, 2012

    Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·March 6, 2014

    Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Product is manufactured and distributed by Philips Healthcare Informatics, Inc. Foster City, CA IntelliSpace PACS are image management systems intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. iSite supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, DX, DR, RE, RT, MG, SC, VL, as well as hospital/radiology information systems.

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare Informatics, Inc.·November 20, 2013

    Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 10, 2013

    Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-TILT, 3/4", Model Number: 2170-3003A; Product is manufactured and distributed by Philips Medical Systems (Cleveland), Inc., Cleveland, OH The BrightView Gamma Camera System is intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel.

    FDA Recall
    Terminated ·Philips Medical Systems·Product code KPS·June 3, 2011

    Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-TILT, 3/8", Model Number: 4535-602-79811; Product is manufactured and distributed by Philips Medical Systems (Cleveland), Inc., Cleveland, OH The BrightView Gamma Camera System is intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel.

    FDA Recall
    Terminated ·Philips Medical Systems·Product code KPS·June 3, 2011

    Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-TILT, 3/8", Model Number: 2170-3002A; Product is manufactured and distributed by Philips Medical Systems (Cleveland), Inc., Cleveland, OH The BrightView Gamma Camera System is intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel.

    FDA Recall
    Terminated ·Philips Medical Systems·Product code KPS·June 3, 2011

    Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-FIXED, 3/8", Model Number: 2170-3000A; Product is manufactured and distributed by Philips Medical Systems (Cleveland), Inc., Cleveland, OH The BrightView Gamma Camera System is intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel.

    FDA Recall
    Terminated ·Philips Medical Systems·Product code -KPS·June 3, 2011

    Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-FIXED, 3/8", Model Number: 4535-602-79781; Product is manufactured and distributed by Philips Medical Systems (Cleveland), Inc., Cleveland, OH The BrightView Gamma Camera System is intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel

    FDA Recall
    Terminated ·Philips Medical Systems·Product code KPS·June 3, 2011

    Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-TILT, 3/4", Model Number; 4535-602-79801; Product is manufactured and distributed by Philips Medical Systems (Cleveland), Inc., Cleveland, OH The BrightView Gamma Camera System is intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel.

    FDA Recall
    Terminated ·Philips Medical Systems·Product code KPS·June 3, 2011

    i-Stat cTnl cartridges Abbott Point of Care Inc. The i-Stat cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac troponin I measurements can be used as an aid in the diagnosis and treatment of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality. The cartridge is to be used with the i-Stat Analyzer, but not with the i-Stat Portable Clinical Analyzer or the Philips Medical System (formerly Agilent Technologies) Blood Analysis Module (BAM). As part of the i-Stat System, the cTnl test is to be used by trained health care professionals in accordance with a facility's policies and procedures.

    FDA Enforcement
    Class II ·Terminated·Abbott Point Of Care Inc.·August 15, 2012

    Precedence System; SYST,PRECEDENCE, 16 SLICE 3/8 Manufactured by Philips Medical Systems (Cleveland), Inc. 595 Miner Road, Cleveland, OH 44143. The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.

    FDA Recall
    Terminated ·Philips Medical Systems·Product code KPS·September 27, 2011

    SKYLight Gamma Camera System; SKYLIGHT, 5/8",SPECT; Manufactured by Philips Medical Systems (Cleveland), Inc. 595 Miner Road, Cleveland, OH 44143. The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.

    FDA Recall
    Terminated ·Philips Medical Systems·Product code KPS·September 27, 2011

    SKYLight Gamma Camera System; SKYLIGHT, 3/8",SPECT; Manufactured by Philips Medical Systems (Cleveland), Inc. 595 Miner Road, Cleveland, OH 44143. The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.

    FDA Recall
    Terminated ·Philips Medical Systems·Product code KPS·September 27, 2011

    Precedence System; SYST,PRECEDENCE, 16 SLICE 5/8 Manufactured by Philips Medical Systems (Cleveland), Inc. 595 Miner Road, Cleveland, OH 44143. The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.

    FDA Recall
    Terminated ·Philips Medical Systems·Product code KPS·September 27, 2011

    Precedence System; SYST,PRECEDENCE, 6 SLICE 3/8 Manufactured by Philips Medical Systems (Cleveland), Inc. 595 Miner Road, Cleveland, OH 44143. The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.

    FDA Recall
    Terminated ·Philips Medical Systems·Product code KPS·September 27, 2011