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    Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FQA·December 4, 2018

    TomoTherapy Hi-ART System, Model # H-0000-0003 Intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or sterotactic radiosurgery to tumors or the targeted tissues.

    FDA Recall
    Terminated ·TomoTherapy Incorporated·Product code MUJ·January 26, 2011

    Hi-Art System, H-0000-0003 Usage: The TomoTherapy Hi-Art System is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non modulated (non-IMRT/three dimensional conformal) format in accordance with the physician approved plan

    FDA Recall
    Terminated ·TomoTherapy Incorporated·Product code MUJ·December 1, 2009

    MRIdian Linac Radiation Therapy System, Model 20000.

    FDA Recall
    Terminated ·Viewray, Inc.·Product code IYE·March 18, 2019

    QUIDEL Sofia SARS Antigen FIA IVD REF 20374

    FDA Recall
    Terminated ·Quidel Corporation·Product code PSZ·September 25, 2020

    Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.

    FDA Recall
    Terminated ·Quidel Corporation·Product code GNX·December 3, 2012

    QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223

    FDA Recall
    Terminated ·Qiagen Sciences LLC·Product code QLT·November 8, 2021

    Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software versions since launch in 2003); Multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments. Software utilized in multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments.

    FDA Recall
    Terminated ·Phadia US Inc·Product code DHB·November 20, 2014

    Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants

    FDA Recall
    Terminated ·Implant Direct Sybron Manufacturing, LLC·Product code DZE·August 9, 2019

    Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia and Sofia 2 instrument intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms.

    FDA Recall
    Terminated ·Quidel Corporation·Product code QKP·September 17, 2020

    ADVIA Centaur CP System, Catalog/Part Number 086-A001. Automated Immunoassay Analyzer. --- Classification of the Device: Under 21 CFR, Part 862.2160, the ADVIA Centaur CP is a discrete photometric chemistry analyzer for clinical use and is classified as a Class I (general control) device. --- The ADVIA Centaur CP is part of Bayer's Immunochemistry analyzer family, which also includes the ADVIA Centaur and the ACS:180. Based on FDA guidance for deciding when regulatory filings are warranted for device modifications, as well as, the FDA Instrument Family and Replacement Reagent Policy Guidance, Bayer determined that the changes associated with the ADVIA Centaur CP did not affect the safety and effectiveness of the predicate device (ACS:180) and therefore no device modification 510(k) was warranted. The ADVIA Centaur CP instrument uses the same reagents as the ADVIA Centaur. The ACS:180 was cleared by FDA under 510(k) # K902336, and the ADVIA Centaur was cleared by FDA under 510(k) # K971418. The ADVIA Centaur CP system was released for sale in November 2005 and distribution of these systems began at that time. All ADVIA Centaur CP Systems are impacted. There is no expiration date for these systems.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics·Product code JJE·November 9, 2006

    STA SYSTEM CONROL N + P (ref. 00678)

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code GGN·November 18, 2019

    STA UNICALIBRATOR (ref. 00675)

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code GIZ·November 18, 2019

    Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images may only be interpreted using an FDA approved monitor that offers at least 5 M pixel resolution and meets other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians an assistants.

    FDA Recall
    Terminated ·Ge Healthcare It·Product code LLZ·June 15, 2012

    Centricity Universal Viewer with PACS-IW foundation 6.0, Model number 2090255-001 Product Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LLZ·May 17, 2019

    Imagecast PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging devices and modalities. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image and interpretations. Mammongraphic may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by the FDA.

    FDA Recall
    Terminated ·Ge Healthcare It·Product code LLZ·March 4, 2011

    Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product Usage: is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging devices and modalities. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by the FDA.

    FDA Recall
    Terminated ·Ge Healthcare It·Product code LLZ·February 18, 2013

    Centricity Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.

    FDA Recall
    Terminated ·GE Healthcare·Product code LLZ·January 25, 2018

    Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.

    FDA Recall
    Terminated ·GE Healthcare·Product code LLZ·January 25, 2018

    Leica Microsystems (Schweiz) Ag. The common name of the device is surgical microscope. It has been assigned the product code FSO by the FDA and is classified as a Class I medical device. Intended for improving the visibility of objects through magnification and illumination.

    FDA Recall
    Terminated ·Leica Microsystems, Inc.·Product code FSO·January 11, 2016