Company: Elekta, Inc. Date of Enforcement Report: 9/4/2019 Class II PRODUCT Monaco Radiation Treatment Planning System (RTP) System Recall Number: Z-2409-2019 REASON Monaco is displaying the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setup Reference Report and is DICOM exporting incorrect (Anatomy/Beam) shift directions. RECALLING FIRM/MANUFACTURER Elekta, Inc. on 8/23/2019. Voluntary: ...Read More

Company: Phadia Ab Date of Enforcement Report: 9/4/2019 Class II PRODUCT Phadia” 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including software for immunodiagnostic testing. The instrument is designed to handle all steps from sample and reagent handling to processing of results. Recall Number: Z-2397-2019 REASON Code 7-102 Liquid...Read More

Company: Spectrum Medical Ltd. Date of Enforcement Report: 9/4/2019 Class I PRODUCT Quantum Pump Console Recall Number: Z-2238-2019 REASON Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use. RECALLING FIRM/MANUFACTURER Spectrum Medical Ltd. on 5/29/2019. Voluntary:  Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE...Read More

Company: Abbott Gmbh & Co. KG Date of Enforcement Report: 9/4/2019 Class II PRODUCT Alinity ci -series System Control Module, Part Number 03R70 01 Product Usage: The Alinity ci series System Control Module has a scalable design to provide full integration of clinical chemistry and immunoassay analysis. The Alinity ci series System Control Module includes...Read More

Company: Agilent Technologies, Inc. Date of Enforcement Report: 9/4/2019 Class II PRODUCT MassHunter Quantitative Analysis Software, Version B.07.01, used with Triple Quadrupole Mass Spectrometers, models K6460 and K6420 Product Usage: A mass spectrometer for clinical use is a device intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by...Read More