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    Architect Sirolimus Reagent Pack; 100 test pack containing 1 bottle (8.0 mL) Anti-Sirolimus Coated Microparticles, 1 bottle (8.0 mL) Sirolimus Acridinium-labeled Conjugate in Citrate Buffer, and 1 bottle (10 mL) Assay Diluent containing saline; Abbott Laboratories, Abbott Diagnostics Division, Abbott Park, IL 60064 USA; list 01L76-25. The Architect Sirolimus assay is chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sirolimus in human whole blood on the Architect i System, as an aid in the management of renal transplant patients receiving sirolimus therapy.

    FDA Recall
    Terminated ·Abbott Laboratories·Product code NRP·May 27, 2010

    Toshiba Aquilion ONE CT SystemTSX-301 A/2D

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAK·February 3, 2009

    Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 WMTS Smart-hopping (1.4GHz) Product Number: 865350 Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262591 USA only SW Revisions: B.05.28, B.05.29, and B.05.32 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code MHX·September 19, 2016

    Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 802.11a/b/g Product Number: 865352 Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262591 Exchange part: 453564262531 453564262551 453564262571 453564262591 453564615351 453564615371 453564467761 (Korea) 453564467781 (Korea) 453564451791 (Japan, Taiwan, Indonesia) 453564451811 (Japan, Taiwan, Indonesia) 453564467821 (Mexico) 453564467841 (China) 453564467861 (China) Worldwide SW Revisions: B.05.28, B.05.29, and B.05.32 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code MHX·September 19, 2016

    Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 Smart-hopping (2.4GHz) Product Number: 865351 Worldwide Except USA Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262591 Exchange part: 453564262531 453564262551 453564262571 453564262591 453564615351 453564615371 453564467761 (Korea) 453564467781 (Korea) 453564451791 (Japan, Taiwan, Indonesia) 453564451811 (Japan, Taiwan, Indonesia) 453564467821 (Mexico) 453564467841 (China) 453564467861 (China) Worldwide except for the USA SW Revisions: B.05.28, B.05.29, and B.05.32 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code MHX·September 19, 2016

    Omnilife Science Apex Knee System Modular Tibia Augment, Size 2 x 4mm Ref: KC-54020. The Apex Knee System is intended for use as a primary or revision total knee replacement.

    FDA Enforcement
    Class II ·Terminated·Omni Life Science·September 19, 2012

    Omnilife Science Apex Knee System Modular Tibia Augment, Size 3 x 4mm Ref: KC-54030. The Apex Knee System is intended for use as a primary or revision total knee replacement.

    FDA Enforcement
    Class II ·Terminated·Omni Life Science·September 19, 2012

    Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm Ref: KC-54050. The Apex Knee System is intended for use as a primary or revision total knee replacement.

    FDA Enforcement
    Class II ·Terminated·Omni Life Science·September 19, 2012

    Omnilife Science Apex Knee System Modular Tibia Augment, Size 4 x 4mm Ref: KC-54040. The Apex Knee System is intended for use as a primary or revision total knee replacement.

    FDA Enforcement
    Class II ·Terminated·Omni Life Science·September 19, 2012

    Omnilife Science Apex Knee System Modular Tibia Augment, Size 1 x 4mm Ref: KC-54010. The Apex Knee System is intended for use as a primary or revision total knee replacement.

    FDA Enforcement
    Class II ·Terminated·Omni Life Science·September 19, 2012

    Omnilife Science Apex Knee System Modular Tibia Augment, Size 6 x 4mm Ref: KC-54060. The Apex Knee System is intended for use as a primary or revision total knee replacement.

    FDA Enforcement
    Class II ·Terminated·Omni Life Science·September 19, 2012

    OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigation System with iBlock (Now OMNIBotics) is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for: Total Knee Arthroplasty

    FDA Enforcement
    Class III ·Terminated·OMNI LIFE SCIENCE·November 23, 2016

    Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve and help the surgeon select a preconfigured prosthesis, or configure the correct size using straight suture material, during mitral valve repair.

    FDA Enforcement
    Class II ·Terminated·On-X Life Technologies, Inc.·February 1, 2017

    Norian Drillable Inject 5 CC-Sterile; catalog # 07.704.005S Intended for bony voids or defects of the extremities and pelvis that are not instrinsic to the stability of the bony structure.

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code MQV·May 11, 2016

    Norian Drillable Inject 3 CC-Sterile; catalog # 07.704.003S Intended for bony voids or defects of the extremities and pelvis that are not intrinsic to the stability of the bony structure.

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code MQV·May 11, 2016

    Norian Drillable Inject 10 CC-Sterile; catalog # 07.704.010S Intended for bony voids or defects of the extremities and pelvis that are not instrinsic to the stability of the bony structure.

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code MQV·May 11, 2016

    Victory Motorized Vehicle, 3 wheel Model SC1600

    FDA Recall
    Terminated ·Pride Mobility Product Corp·Product code INI·July 1, 2004

    Victory Motorized Vehicle 4 wheels Model SC1700

    FDA Recall
    Terminated ·Pride Mobility Product Corp·Product code INI·July 1, 2004

    Chauffeur Powered Scooters.

    FDA Recall
    Terminated ·Electric Mobility Corp·Product code INI·February 7, 2003

    Electric Mobility Corporation (EMC)- Scooters and Turnabout Powerchairs with either an Electric Seat Lift Actuator or a Seat Post to attach the seat to the vehicle; Model Number(s) 300F, 600C, 600T, and 600F. Electronic Mobility Corporation, 599 Mantua Blvd, One Mobility Plaza, Sewell, NJ 08080

    FDA Recall
    Terminated ·Electric Mobility Corp·Product code INI·March 22, 2007