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FDA: Medical Device Information For Consumers
Items added to the Center for Devices and Radiological Health's Consumer website within the last month.
Updated: 26 min 13 sec ago
Consumer Information on: OraQuick HCV Rapid Antibody Test - P080027
The OraQuick HCV Rapid Antibody Test is used to detect a patient?s exposure to the hepatitis C virus (HCV). Antibodies are proteins produced by the body to fight against foreign substances, such as viruses and bacteria. The presence of the antibodies...
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Class I Medical Device Recall: Alcon Research LTD doing business as Alcon Laboratories, Inc. - CONSTELLATION Vision System
Alcon initiated the recall after it identified both software and hardware problems which have been associated with unexpected system loss of power (shutdowns), unintended system error messages, unresponsive touchscreens, and system setting and infusion pe
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Consumer Information on: Implantable Miniature Telescope - P050034
The VisionCare Ophthalmic Technologies Implantable Miniature Telescope TM (IMT) is a system to magnify objects to improve vision in patients with end-stage, age-related macular degeneration (AMD). The IMT is surgically implanted in one eye only and is...
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Class I Medical Device Recall: Symbiq One-Channel Infuser and Symbiq Two-Channel Infuser
There is potential for the device to fail to detect air in line at the end of an infusion.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Class I Medical Device Recall: Cepheid Xpert MRSA/SA Blood Culture Assay for Use with the GeneXpert Dx System
Reason for Recall: The firm received increasing numbers of complaints for false negative MRSA results when compared to MRSA positive results received from culture methods. All Cepheid MRSA/SA Blood Culture Assay products have a potential of generating...
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Class I Medical Device Recall: Physio-Control Inc., LIFEPAK 20 and LIFEPAK 20e External Defibrillator/Monitors
A failure on the power supply assembly can result in either "No DC power" or "No DC or AC power". A failure of DC (battery) power can result in the inability to deliver defibrillation therapy if the device will not turn on using DC (battery) power and...
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Consumer Information on: Photodynamic Diagnostic D-Light C (PDD) System - P050027
The Karl Storz Photodynamic Diagnostic D-Light C (PDD) System is used as an optional accessory to white light cystoscopy when used in combination with the diagnostic imaging drug Cysview® (Photocure ASA, a Norwegian pharmaceutical company).
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Class I Medical Device Recall: Defibtech LLC, DBP-2800 Battery Pack for ReviveR AED? and Lifeline AED® Semi-automatic External Defibrillators
Reason for Recall: If the AED is used with an affected battery pack, the AED may falsely detect an error condition, cancel charge and not provide therapy.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Consumer Information on: Elecsys® Anti-HCV Immunoassay and Elecsys® PreciControl Anti-HCV on the cobas e 411 Immunoassay Analyzer - P090007
The Elecsys® Anti-HCV Immunoassay is a laboratory test used to detect antibodies associated with the hepatitis C virus (HCV) infection. Antibodies are proteins produced by the body to fight against foreign substances, such as viruses and bacteria.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Consumer Information on: Elecsys® Anti-HCV Immunoassay and Elecsys® PreciControl Anti-HCV on the cobas e 601 Immunoassay Analyzer - P090008
The Elecsys® Anti-HCV Immunoassay is a laboratory test used to detect antibodies associated with the hepatitis C virus (HCV) infection. Antibodies are proteins produced by the body to fight against foreign substances, such as viruses and bacteria.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Consumer Information on: Elecsys® Anti-HCV Immunoassay and Elecsys® PreciControl Anti-HCV on the MODULAR ANALYTICS E170 Immunoassay Analyzer - P090009
The Elecsys® Anti-HCV Immunoassay is a laboratory test used to detect antibodies associated with the hepatitis C virus (HCV) infection. Antibodies are proteins produced by the body to fight against foreign substances, such as viruses and bacteria.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Consumer Information on: Ethicon? OMNEX? Surgical Sealant - P060029
Ethicon? OMNEX? is a medical sealant that is used to help stop leaks in blood vessels. It is made of two synthetic components called cyanoacrylate monomers, and does not include any human or animal materials.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Class I Medical Device Recall: Counterfeit Polypropylene Surgical Mesh Products Marketed as C. R. Bard/Davol
Various sizes of counterfeit flat sheets of polypropylene surgical mesh have been marketed in the United States labeled with the C. R. Bard/Davol brand name. These meshes, specifically identified below, are NOT Bard-manufactured products.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Consumer Information on: Esteem® Implantable Hearing System - P090018
The Esteem® is the first totally implantable hearing system used to treat moderate to severe hearing loss caused by a defective inner ear function. The Esteem® system includes three implantable components (Sound Processor, Sensor, and Driver), and externa
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Consumer Information on: Asthmatx, Inc. Alair Bronchial Thermoplasty System - P080032
The Alair Bronchial Thermoplasty System is composed of a catheter with an electrode that delivers radiofrequency energy2 (a form of electromagnetic energy) directly to the airways of the lungs. A controller unit generates and controls the energy.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Class I Medical Device Recall: Certain Cuffed Shiley Tracheostomy Tubes
Reason for Recall: The company has voluntarily recalled this device because they may leak air, resulting in inadequate ventilation.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Class I Medical Device Recall: GE Healthcare Aisys and Avance Anesthesia Systems
The Aisys and Avance Anesthesia Systems are prescription devices used in healthcare settings under the supervision of a physician. They are intended to provide general inhalation anesthesia and ventilation support to a wide range of patients. These device
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Class I Medical Device Recall: Cardiac Science Corporation, Powerheart, CardioVive, Nihon Kohden, and GE Responder Automated External Defibrillators (AEDs)
Reason for Recall: Certain models of Powerheart G3 AEDs may not have received adequate electrical safety testing prior to being shipped from the factory.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Consumer Information on: Quick-Close Vascular Suturing System - P080029
The Quick-Close Vascular Suturing System is used to stop the bleeding of a puncture site following a surgical procedure using the major artery of the thigh (femoral artery).
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Consumer Information on: Softec HD Aspheric Posterior Chamber Intraocular Lens - P090022
The Softec HD posterior chamber intraocular lens (IOL) is an artificial lens used to restore vision and replace the natural lens of the eye after it is removed during cataract surgery.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
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