Qualigen Inc - FastPack Vitamin D Immunoassay - Class 2 Recall
FastPack¿ Free T4 Immunoassay FastPack¿ Vitamin D Immunoassay Chemilunescence assay for the determination of Vitamin D K123983 Vitamin D The FastPack¿ Vitamin D Immunoassay is intended for the quantitative determination of FastPack¿ Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA FastPack¿ Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 20, 2013 Category: Medical Equipment Source Type: alerts
Qualigen Inc - FastPack Total PSA Immunoassay - Class 2 Recall
FastPack¿ Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. K994419 Total PSA FastPack¿ Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer. The FastPack¿ Total PSA Immunoassay is designed for use with the FastPack¿ System. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 20, 2013 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc - ARTISTE Linear Accelerator - Class 2 Recall
SIEMENS brand ARTISTE Linear Accelerator Linac systems with component: any photon unflat beam option (Multiple X feature) in combination with the IMRT or mARC option. A family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. The ARTISTE/ONCOR systems are manufactured by: SIEMENS AG, MEDICAL SOLUTIONS, Roentgenstrasse 19-21, Kemnath, GERMANY 95478 and distributed SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Martinez, CA (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 4, 2013 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc - ONCOR series Linear Accelerator - Class 2 Recall
SIEMENS brand ONCOR series Linear Accelerator Linac systems with component: any photon unflat beam option(Multiple X feature) in combination with the IMRT or mARC option. A family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. The ARTISTE/ONCOR systems are manufactured by: SIEMENS AG, MEDICAL SOLUTIONS, Roentgenstrasse 19-21, Kemnath, GERMANY 95478 and distributed SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Martinez, CA. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 4, 2013 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615 - Class 2 Recall
GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615. The GE Discovery NMJCT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM/CT 670 system, combining Nuclear Me...
Source: Medical Device Recalls - November 21, 2013 Category: Medical Equipment Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Ingenuity TF PET/CT - Class 2 Recall
Ingenuity TF PET/CT Diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) systems. The CT subsystem produces cross sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other Oran imaging). Attenuation correction is accomplished by CTAC. The device also provides for list mode, dynamic, and gated acquisitions. Image processing and ...
Source: Medical Device Recalls - October 26, 2013 Category: Medical Equipment Source Type: alerts
Hologic, Inc. - Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x - Class 2 Recall
Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer. The Selenia Full Field Digital Mammography System is intended for use in the same clinical applications as traditional screen-film mammography systems. Mammography images can be interpreted on either hard copy film or soft copy review workstations, cleared for mammography (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 1, 2013 Category: Medical Equipment Source Type: alerts
Assuramed - Hemoccult II SENSA elite - Class 2 Recall
Hemoccult II BRAND SENSA elite; MATERIALS AND REAGENTS; Hemoccult II SENSA elite Slides (Test Cares) containing guaiac paper; Hemoccult SENSA Developer-a developing solution containing a stabilized mixture of less than 4.2% hydrogen peroxide, 80% denatured ethyl alcohol and enhancer in an aqueous solution; Applicator Sticks; Patient Screening Kit Dispensing Envelopes with Patient Instructions; Flushable Collection Tissues; Mailing Pouches (for returning completed Test Cares); Hemoccult II SENSA elite Product Instructions; Beckman Coulter, Inc.; 250 S. Kraemer Blvd.; Brea, CA 92821 The Hemoccult II SENSA elite test is a ...
Source: Medical Device Recalls - September 14, 2013 Category: Medical Equipment Source Type: alerts
Becton Dickinson & Co. - PrepStain Tecan USI - Class 2 Recall
PrepStain Tecan US-I. For use in the screening and detection of cervical cancer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 29, 2013 Category: Medical Equipment Source Type: alerts
Becton Dickinson & Co. - PrepStain Tecan USII - Class 2 Recall
PrepStain Tecan US-II. For use in the screening and detection of cervical cancer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 29, 2013 Category: Medical Equipment Source Type: alerts
Becton Dickinson & Co. - PrepStain AG - Class 2 Recall
PrepStain AG. For use in the screening and detection of cervical cancer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 29, 2013 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc - PRIMUS, ONCOR, ARTISTE Linac systems - Class 2 Recall
PRIMUS, ONCOR, ARTISTE Linac systems with component Tabletop, 550TxT, TT-A s/n 1001-1233 and Tabletop 550TxT, TT-S s/n 1001-1083. Product Usage: The intended use of the SIEMENS branded, ARTISTE , ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 27, 2013 Category: Medical Equipment Source Type: alerts
Siemens Healthcare Diagnostics - IMMULITE - Class 2 Recall
PSA Assays for use in the IMMULITE/IMMULITE 1000 Systems Analyzers, Catalog Numbers LKPS1, LKPS5 and LKPTS1(D); and in the IMMULITE 2000/2000XPi Systems Analyzers, Catalog Numbers L2KPS2, L2KPS6, L2KPTS2(D) and L2KPTS6(D). IVD Immunoassay kits in the following sizes: 100, 200, 500 and 600 test kits; For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 and the IMMULITE 2000/ 2000 XPi Systems Analyzers. PMA # P930027/ Device Listing # D002374. Product Usage: For the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of prostate cancer when used in conjunction w...
Source: Medical Device Recalls - August 24, 2013 Category: Medical Equipment Source Type: alerts
Veridex, LLC - CELLTRACKS ANALYZER II - Class 2 Recall
CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below. Product Usage: The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. Cell analyzers such as the CellTracks Analyzer II, CellSpotter System, flow cytometers or microscopes may be used for cell identification and enumeration. The system is fit for in vitro diagnostic use. In the CellTracks Analyzer II software 2.5.1 release notes Pub. No. J40136EN issued 2012-03-26 page 1, the document states that the edit p...
Source: Medical Device Recalls - August 11, 2013 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - Discovery NM630 - Class 1 Recall
Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Product Usage: The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM 630 syste...
Source: Medical Device Recalls - July 25, 2013 Category: Medical Equipment Source Type: alerts
