GE Healthcare - GE Healthcare, SIGNA PET/MR 3.0T - Class 2 Recall
GE Healthcare, SIGNA PET/MR 3.0T. Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high-resolution physiologic and anatomic information, acquired simultaneously and isocentrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders. Th...
Source: Medical Device Recalls - November 10, 2015 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc - ONCOR , PRIMUS HI, PRIMUS MidEnergy, MEVATRON M2, ARTISTE - Class 2 Recall
ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, MEVATRON M2/PRIMUS Mid-Energy, ARTISTE; intended use is to deliver x-ray radiation for therapeutic treatment of cancer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 28, 2015 Category: Medical Equipment Source Type: alerts
Elekta, Inc. - XiO Radiation Treatment Planning System - Class 2 Recall
XiO Radiation Treatment Planning System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 17, 2015 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc - ARTISTE, ONCOR Avantgarde, Impression Plus, and Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist - Class 2 Recall
ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of cancer Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer. Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient ...
Source: Medical Device Recalls - September 25, 2015 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc. - Class 2 Recall
The Siemens Symbia T Series is a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) camera system for nuclear medicine images, and a computed tomography (CT) camera system for x-ray images. Product Usage: Indications for use: The Siemens Symbia T series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer...
Source: Medical Device Recalls - August 21, 2015 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc. - Class 2 Recall
The Siemens Intevo Series system is a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) camera system for nuclear medicine images, and a computed tomography (CT) camera system for x-ray images. Product Usage: Indications for use: The Siemens Symbia T series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and c...
Source: Medical Device Recalls - August 21, 2015 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc. - Class 2 Recall
The Siemens Symbia S Series system is a diagnostic analog or digital detector based planar (2- dimensional) nuclear medicine (NM) imaging system installed and used in only one location within an imaging facility or in a mobile/ transportable imaging environment. Product Usage: Indications for use: The Siemens Symbia T series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological di...
Source: Medical Device Recalls - August 21, 2015 Category: Medical Equipment Source Type: alerts
Roche Molecular Systems, Inc. - Roche Molecular Diagnostics - Class 3 Recall
cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Intended for the identification of mutations in codons 12,13 and 61 of the KRAS Gene in DNA derived from formalin-fixed paraffin-embedded human colorectal and non-small cell lung cancer tissues. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2015 Category: Medical Equipment Source Type: alerts
FLUDEOXYGLUCOSE F 18 (Fludeoxyglucose F 18) Injection [The University Of Utah DBA Cyclotron Radiochemistry Lab / Huntsman Cancer Institute]
Updated Date: Jun 25, 2015 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))
Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) - June 25, 2015 Category: Drugs & Pharmacology Source Type: alerts
Elekta, Inc. - Oncentra Brachy treatment planning system - Class 2 Recall
Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 5, 2015 Category: Medical Equipment Source Type: alerts
Fujifilm Medical Systems U.S.A., Inc. - Fujifilm Aspire HD, Full Field Digital, System - Class 2 Recall
Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-1000. A mammography system used for screening and diagnosis of breast cancer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 7, 2015 Category: Medical Equipment Source Type: alerts
SODIUM FLUORIDE F 18 (Sodium Fluoride F 18) Injection [The University Of Utah DBA Cyclotron Radiochemistry Lab Huntsman Cancer Institute]
Updated Date: May 5, 2015 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))
Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) - May 5, 2015 Category: Drugs & Pharmacology Source Type: alerts
Therasage, LLC. - FARInfrared Heat Home Sauna, 2 person - Class 2 Recall
FAR-Infrared Heat Home Sauna, 2 person Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme Disease, and ... to reduce neurosis and anxiety . (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 29, 2015 Category: Medical Equipment Source Type: alerts
Therasage, LLC. - Portable FAR Infrared Sauna - Class 2 Recall
Portable FAR Infrared Sauna Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme Disease, and ... to reduce neurosis and anxiety . (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 29, 2015 Category: Medical Equipment Source Type: alerts
Therasage, LLC. - FARInfrared Heat Home Sauna, 3 person - Class 2 Recall
FAR-Infrared Heat Home Sauna, 3 person Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme Disease, and ... to reduce neurosis and anxiety . (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 29, 2015 Category: Medical Equipment Source Type: alerts
