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    ASTS-LG1212: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 12 degrees lordosis, 12 mm height and ASTS-LG0612: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 6 degrees lordosis, 12 mm height

    FDA Recall
    Terminated ·Product code MAX·September 29, 2014

    Centricity Enterprise Web 3.0 software; the software allows physicians convenient, quick access to medical images and related data they need via a web browser, password and a standard PC; GE Healthcare Integrated IT Solutions, Barrington, IL 60010.

    FDA Recall
    Terminated ·GE Healthcare Integrated IT Solutions·Product code LMD·December 12, 2008

    Vital Images ViTALConnect , Version 4.0 and 4.1, PET/CT Visualization option. Vital Images, Inc., 5850 Opus Parkway, Suite 300, Minnetonka, MN 55343. ( A web-based medical diagnostic tool that allows physicians to use PCs or notebook computers to gain remote access to 2D, 3D, and 4D advanced visualization. The software enables users to measure, rotate, and analyze images)

    FDA Recall
    Terminated ·Vital Images, Inc.·Product code LLZ·November 8, 2007

    The GE Centricity Web; Software Version 3.0x, is intended for use under the direct supervision of a licensed healthcare practitioner. The Centricity Enterprise Web is an image and information distribution system for the clinical review of medical images and reports. The Centricity Enterprise Web is not intended for primary diagnosis. The Centricity Enterprise Web is available as a supplemental sub-system to Centricity PACS or as a stand alone Web-based image and information distribution system. The Centricity Enterprise Web provides both the server software and a client application, which utilizes off the shelf browser technology. Centricity Enterprise Web supports several interface protocols which allows the system to be integrated with any image or information systems such as a hospital information system (HIS), radiology information system (RIS), or electronic medical record (EMR), which supports one of the supported integration protocols.

    FDA Enforcement
    Class II ·Terminated·Ge Healthcare It·December 11, 2013

    The GE Centricity Web; Software Version 3.0x, is intended for use under the direct supervision of a licensed healthcare practitioner. The Centricity Enterprise Web is an image and information distribution system for the clinical review of medical images and reports. The Centricity Enterprise Web is not intended for primary diagnosis. The Centricity Enterprise Web is available as a supplemental sub-system to Centricity PACS or as a stand alone Web-based image and information distribution system. The Centricity Enterprise Web provides both the server software and a client application, which utilizes off the shelf browser technology. Centricity Enterprise Web supports several interface protocols which allows the system to be integrated with any image or information systems such as a hospital information system (HIS), radiology information system (RIS), or electronic medical record (EMR), which supports one of the supported integration protocols.

    FDA Recall
    Terminated ·Ge Healthcare It·Product code LMD·April 19, 2012

    Terumo(tm) Hypodermic Needle, sterile, individually packaged into a "blister-pack" flexible plastic bottom-web thermo-formed to create a pocket, heat-sealed with paper top-web,1,000 needles per case. Product Usage: Aspiration and injection of fluids for medical purposes.

    FDA Recall
    Terminated ·Terumo Medical Corporation·Product code FMI·June 8, 2010

    GE Centricity Web Diagnostic (WebDX) software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. Device that receives, stores and communicates medical images and data from various imaging sources.

    FDA Recall
    Terminated ·Ge Healthcare It·Product code LLZ·February 11, 2010

    RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001. This is a web application software hosted on a server. There is no physical product.

    FDA Recall
    Terminated ·Roche Diabetes Care, Inc.·Product code JQP·March 9, 2022

    Video Duodenoscope

    FDA Recall
    Terminated ·Pentax Medical Company·Product code FDT·February 22, 2016

    Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources within the system or across computer networks at distributed locations.

    FDA Enforcement
    Class II ·Terminated·Ge Medical Systems Information T·April 19, 2017

    Toddler Chair Hip Strap (Belt). The hip belt is made with nylon webbing and a plastic buckle. 510(k) exempt, Medical Device Listing # R061877. The product is used as a hip strap chair for children.

    FDA Recall
    Terminated ·Community Products, LLC·Product code INN·September 12, 2008

    Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources within the system or across computer networks at distributed locations.

    FDA Recall
    Terminated ·Ge Medical Systems Information T·Product code LLZ·February 18, 2013

    GE Centricity Web Diagnostic 1.0(WebDX) software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Intended use:The Centricity PACS-IW is used to receive 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.

    FDA Recall
    Terminated ·Ge Healthcare It·Product code LLZ·February 18, 2010

    U19 Socketed Integrated Circuit ("U19 IC") on the logic board of Alaris Pump modules (aka. Medley Pump modules), Model 8100 built on or before September 8, 2005. CardinalHealth, San Diego, CA 92130

    FDA Recall
    Terminated ·Cardinal Health 303 Inc DBA Alaris Products·Product code FRN·March 5, 2008

    U9 Socket Integrated Circuit ("U9 IC") on the display board of the following Alaris System modules built on or before October 4, 2005: (1) Alaris Syringe module (Model 8110) (a.k.a. Medley Syringe module) (2) Alaris PCA module (Model 8120) (a.k.a. Medley PCA module), CardinalHealth, San Diego, CA 92130

    FDA Recall
    Terminated ·Cardinal Health 303 Inc DBA Alaris Products·Product code FRN·March 5, 2008

    Grey Inter-Unit Interface Connectors ("IUI") on the following Alaris System modules built on or before March 26, 2004: (1) Alaris PC point-of-care unit ("PC Unit") (Model 8000)* (a.k.a. Medley PC Unit), (2) Alaris Pump Module (Model 8100) (a.k.a. Medley Pump Module), (3) Alaris Syringe Module (Model 8110) (a.k.a. Medley Syringe Module), (4) Alaris PCA Module (Model 8120) (a.k.a. Medley PCA Module), (5) Alaris SpO2 Module (Models 8210) (a.k.a. Medley SpO2 Module) with Nellcor technology, and (6) Alaris SpO2 Module (Models 8220) (a.k.a. Medley SpO2 Module) with Masimo technology, CardinalHealth, San Diego, CA 92130

    FDA Recall
    Terminated ·Cardinal Health 303 Inc DBA Alaris Products·Product code FRN·March 5, 2008

    Cardinal Health Alaris Pump Module (formerly Medley Pump Module), Model 8100, Cardinal Health, San Diego, CA. (All Alaris Pump modules shipped prior to December 23, 2007 are subject to this recall)

    FDA Recall
    Terminated ·Cardinal Health 303 Inc DBA Alaris Products·Product code FRN·October 29, 2007

    Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150, EX1150W, EX1100, and EX1100W. The Merlin@home Transmitters are a component of St. Jude Medicals (SJM) Remote Care System. These Merlin@home transmitters are used to retrieve information from the SJM implantable medical device (IMD) using RF telemetry. The data is then sent back to the Merlin.net Patient Care Network through a built-in modem or, alternatively, through a USB cellular adapter or a USB based Broadband Kit. The transmitted data enables clinicians to remotely monitor a patients IMD using a secure, encrypted, password-protected web site, thus reducing the number of in-clinic visits a patient needs to make to their physician. The transmitter monitors the patients device daily between scheduled follow-ups and can alert a clinician if it detects anything out of the norm.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150, EX1150W, EX1100, and EX1100W. The Merlin@home Transmitters are a component of St. Jude Medicals (SJM) Remote Care System. These Merlin@home transmitters are used to retrieve information from the SJM implantable medical device (IMD) using RF telemetry. The data is then sent back to the Merlin.net Patient Care Network through a built-in modem or, alternatively, through a USB cellular adapter or a USB based Broadband Kit. The transmitted data enables clinicians to remotely monitor a patients IMD using a secure, encrypted, password-protected web site, thus reducing the number of in-clinic visits a patient needs to make to their physician. The transmitter monitors the patients device daily between scheduled follow-ups and can alert a clinician if it detects anything out of the norm.

    FDA Recall
    Terminated ·St Jude Medical Inc.·Product code OSR·August 28, 2017

    GE Healthcare CIC Pro" Software Versions 5.0.3, 5.0.6 ,5.0.7, 5.0.8 and 4.1. The CIC Pro" Clinical Information Center Central Station is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use is to provide clinicians with adult, pediatric and neonatal patient data in a centralized location within a hospital or clinical environment. The CIC Pro Central Station is intended to collect information from a network and display this data. This data included physiological, patient demographic and/or other non-medical information. Physiological parameters and waveforms from GE Healthcare Information Technologies monitors and telemetry systems can be displayed and printed from the CIC Pro Clinical Information central station. Beat to beat patient information for all parameters and waveforms from he bedsides and telemetry systems can be displayed. The CIC Pro Clinical Information Center central station supports the ability to access information from GE Medical Systems Information Technologies products in web browser format. Additionally, the CICC Pro clinical Information central station supports the ability to access patient information collected from the unity network and stored on a network server.

    FDA Recall
    Terminated ·GE Medical Systems Information Tecnology 9900 Inovation Drive RP 2122 3rd Floor Wauwatosa WI 53226·Product code DSI·February 27, 2009