BEUDAMED
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    SYS IVK, Bio mCT-S(40) 3R->4R, Model Number 10250743

    FDA Recall
    Terminated ·Siemens Medical Solutions USA Inc.·Product code KPS·July 14, 2015

    SYS IVK, Bio mCT-S(40) 3R->4R, Model Number 10250743

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA Inc.·August 12, 2015

    SYS IVK, Bio mCT-S(40) 3R->4R Upgrade, MATERIAL NUMBER 10250743 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA Inc.·June 29, 2016

    SYS IVK, Bio mCT-X 3R->4R Upgrade, MATERIAL NUMBER 10250745 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA Inc.·June 29, 2016

    SYS IVK, Bio mCT-S(40) 3R->4R Upgrade, MATERIAL NUMBER 10250743 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA Inc.·Product code KPS·April 22, 2016

    SYS IVK, Bio mCT-X 3R->4R Upgrade, MATERIAL NUMBER 10250745 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA Inc.·Product code KPS·April 22, 2016

    ACUSON X700 Ultrasound System with software version 1.0.04. Model numbers: 10658844  ACUSON X700 Ultrasound System 10658846 - ACUSON X700 Ultrasound System (Russia) 10658845 - ACUSON X700 Ultrasound System (Korea) Radiology: The Siemens ACUSON X700 ultrasound imaging system is intended for the following applications: Cardiac (Adult, Pediatric), Transesphageal (Cardiac), Intracardiac, Cerebrovascular, Peripheral Vessel, Abdominal, Renal, Fetal, Abdominal, Intra-operative, Pediatric, Small Organ, Neonatal Cepahalic, Adult Cephalic, Orthopedics, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Pelvic, Obstetrical, Gynecological and Urological applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 4, 2016

    2 pc Full Overlap Vest & Kilt, Single Item, Product Number FVK, Part Numbers REFVK*F, REFVK*M, REFVKB, REFVKD, REFVKE, REFVKF, SEFVK*F, SEFVK*M, SEFVKE, SEFVKXLM Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.

    FDA Enforcement
    Class II ·Terminated·Burlington Medical, LLC·August 7, 2019

    2 pc Full Overlap Vest & Kilt, Single Item, Product Number FVK, Part Numbers REFVK*F, REFVK*M, REFVKB, REFVKD, REFVKE, REFVKF, SEFVK*F, SEFVK*M, SEFVKE, SEFVKXLM Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.

    FDA Recall
    Terminated ·Burlington Medical, LLC·Product code EAJ·June 7, 2019

    Dual Luer Lock Cap The device is intended for use as a cap for male or female Luer ports on medical devices such as manifolds, stopcocks or sets.

    FDA Recall
    Terminated ·Baxter Healthcare Corp.·Product code OBK·September 10, 2013

    SoftLase Pro Dental Lasers: Zap SoftLase, SoftLase Pro, OrthoLase, and HygieneLase models, Model numbers ZA-SLP, ZA-ORT, ZA-HYG, G22002SLP, ZA-SOFTLASE2WSII, ZA-SOFTLASER2W, Manufactured by Zap Lasers LLC, Pleasant Hill, CA. Intended use: Dentistry.

    FDA Recall
    Terminated ·Zap Lasers LLC·Product code NVK·August 8, 2008

    Monitor portion of the LifeVest device - specifically the Defibrillator printed circuit assembly (PCA) within the monitor. The LifeVest is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.

    FDA Recall
    Terminated ·Zoll Lifecor Corporation·Product code MVK·October 21, 2008

    Model 4000 Monitor component of the LifeVest Wearable Defibrillator

    FDA Recall
    Terminated ·Zoll Lifecor Corporation·Product code MVK·September 24, 2010

    Electrode Belt, component of the LifeVest Wearable Defibrillator, Product number 10A0889-A01. Specifically the 3 Therapy Electrode Pads attached to the Electrode Belt.

    FDA Recall
    Terminated ·Zoll Lifecor Corporation·Product code MVK·April 27, 2007

    LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. The LifeVest system is indicated for patients 18 years of age and older who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.

    FDA Recall
    Terminated ·Zoll Manufacturing Corp.·Product code MVK·September 12, 2017

    Battery Pack portion of the LifeVest device. The LifeVest is a wearable cardioverter defibrillator worn by a patient at risk for sudden cardiac arrest (SCA).

    FDA Recall
    Terminated ·Zoll Lifecor Corporation·Product code MVK·September 14, 2007

    EASYMax N. Self-Monitoring Blood Glucose System, distributed in cardboard carton kits. Each kit contains the following components: Blood Glucose Meter; Test Strip x 10 ct.; Normal Control Solution; Carrying Case; Alkaline Battery x 2 ct.; Lancets x 5 ct.; Lancing Device; AST Lancing Device Cap; User's Manual; Test Strip Instructions and Control Solution Instructions. Indicated for use at home by persons with diabetes or in clinical setting by healthcare professionals as an aid to monitor the effectiveness of diabetes control.

    FDA Recall
    Terminated ·Oak Tree International Holdings, LLC, Inc.·Product code NBW·May 26, 2009

    Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator

    FDA Recall
    Terminated ·Sorin CRM SAS Cvk 4, avenue Reaumur Clamart Cedex France·Product code NIK·July 9, 2018

    Endoform Dermal Template 2x2, SKU 529312 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist wound environment.

    FDA Recall
    Terminated ·AROA BIOSURGERY 2 Kingsford Smith Place Airport Oaks New Zealand·Product code KGN·November 27, 2018

    Endoform Dermal Template 2x2, SKU 529311 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist wound environment.

    FDA Recall
    Terminated ·AROA BIOSURGERY 2 Kingsford Smith Place Airport Oaks New Zealand·Product code KGN·November 27, 2018