7 results
·
61ms
·
Sources: EU EUDAMED, US FDA
9.6 PINNACLE 3 SW
FDA Adverse Event
Malfunction
·PHILIPS NUCLEAR MEDICINE, INC·Product code MUJ·January 18, 2014
PRECEDENCE SPECT/CT
FDA Adverse Event
Malfunction
·PHILIPS NUCLEAR MEDICINE, INC·Product code KPS·September 14, 2007
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
FDA Adverse Event
Other
·PHILIPS NUCLEAR MEDICINE, INC.·Product code MUJ·September 12, 2007
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
FDA Adverse Event
Malfunction
·PHILIPS NUCLEAR MEDICINE, INC·Product code MUJ·August 21, 2007
The Pinnacle3 Radiation Therapy Planning (RTP) system and its associated software; composed of several modules including the core Pinnacle3 functionality, Syntegra (TM), P3IMRT, P3MD and AcQSim3 (TM). The Pinnacle3 RTP system is composed of a Sun UNIX workstation (or UNIX-complaint computer) running the Solaris operating system and software, and a UNIX terminal emulation package on a personal computer, which allows the user to enter patient data into the system, use that data to construct a plan for radiation therapy, and evaluate the plan- Philips Medical Systems-Model #9200-0652A-ENG, 9200-0700A-ENG, 9200-0700B-ENG, 9200-0700C-ENG (with software versions 7.6C, 8.0d and 8.0h)
FDA Recall
Terminated
·Philips Nuclear Medicine, Inc.·Product code MUJ·August 21, 2007
Precedence SPECT/CT System, Precedence 16 3/8, Upper Patient Pallet, A single photon nuclear medicine and image from an X-ray computed tomography system, Model Number: 4535 602 50851, Catalog Number: 882350, Product is manufactured by Philips Medical Systems (Cleveland), Inc. Cleveland, OH Intended use: A single photon nuclear medicine and image from an X-ray computed tomography system.
FDA Recall
Terminated
·Phillips Nuclear Medicine·Product code INQ·January 26, 2009
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 Recall
Terminated
·Philips Medical Systems (Cleveland), Inc.·Product code IYE·October 5, 2012