Aroa Biosurgery - Endoform Dermal Template - Class 2 Recall
Endoform Dermal Template 4x5, SKU 529313 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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 3, 2018 Category: Medical Devices Source Type: alerts
Aroa Biosurgery - Endoform Dermal Template - Class 2 Recall
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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 3, 2018 Category: Medical Devices Source Type: alerts
Fresenius Vial Sa - Volumat MC Agilia - Class 2 Recall
Volumat MC Agilia Volumetric Infusion Pump, Model No. Z021135, Software version 1.7. Product Usage - The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare facilities environment by healthcare trained professionals according to hospital protocols on adults, pediatrics and neonatal human patient to administer via a single channel or mounted on a multiple channels rack accessory: Intermittent or continuous delivery of parenteral fluids (solutions, colloids, parenteral nutrition) and medications (including but limited to diluted drugs, chemotherapy) through clinically accepted IV...
Source: Medical Device Recalls - November 2, 2018 Category: Medical Devices Source Type: alerts
Acumedia Manufacturers, Inc. - Palcam Agar Base, Acumedia - Class 3 Recall
Palcam Agar Base, Acumedia, PN 7669, Product Usage - Dehydrated culture media used with supplements as a selective and differential medium for the detection and isolation of Listeria monocytogenes from foods and environmental samples in a laboratory setting. Not intended for use in the diagnosis of disease or other conditions in humans. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 27, 2018 Category: Medical Devices Source Type: alerts
GE Medical Systems, LLC - System, Nuclear Magnetic Resonance Imaging - Class 2 Recall
SIGNA Architect system Product Usage: The Signa Architect system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest ...
Source: Medical Device Recalls - October 25, 2018 Category: Medical Devices Source Type: alerts
Widex A/S - WIDEX BABY440 - Class 2 Recall
Widex BABY hearing aid (referred to as BABY440), powered by zinc-air batteries size 10 Intended use: BABY440 is intended for, but not limited to, babies (0 to 3 years of age) to be used as air conduction amplification devices in everyday listening environments. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 11, 2018 Category: Medical Devices Source Type: alerts
Radiometer America Inc - The ABL90 FLEX Analyzer - Class 2 Recall
ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. It is intended for use in a laboratory environment, near patient or point-of-care setting. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 2, 2018 Category: Medical Devices Source Type: alerts
Boston Scientific Corporation - LATITUDE Programming System - Class 2 Recall
Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the Pulse Generator (PG). Detailed software applications instructions can be found in the associated product literature for the PG being interrogated. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 28, 2018 Category: Medical Devices Source Type: alerts
GE Medical Systems, LLC - Discovery MR750w - Class 2 Recall
Discovery MR750w Nuclear Magnetic Resonance Imaging System labeled as the following product name sold under: Product Name (Model Number): A. 3.0T MR750 32CH (911000-3); B. 3.0T MR750W (5911000-3, 5481490-2, 5499460-7, 5499460-10, 5373011-3, 5352293, 5911000-3); C. 3.0T MR750W GEM (5499460-10, 5481490-2); D. 3.0T MR750W GEM ENAB (5911000-3); E. 3.0T MR750W GEM ENABLED (5352293, 5481490-2, 5481490-2, 5396469-3, 2394952-100, 5911000-3, 5373011-3); F. 3.0T MR750W GEM ENABLED PLU (5352293); G. 3.0T MR750W GEM ENABLED PLUS (5352293, 5499460-10); H. 3.0T MR750W W GEM (5352293, 5911000-3); I. 3.0T MR750W WITH GEM (5...
Source: Medical Device Recalls - September 28, 2018 Category: Medical Devices Source Type: alerts
Stryker Medical Division of Stryker Corporation - IsoFlex LAL(R) - Class 2 Recall
IsoFlex LAL Support Surface, Model Number 2860 Product Usage: : The IsoFlex LAL support surface assists in the prevention and treatment of all pressure injuries (including stages 1,2,3,4, unstageable injury, and deep tissue injury) and is recommended to be implemented in combination with clinical evaluation of risk factors and skin assessments made by a health care professional. This support surface is for use with human patients with existing or at risk of incurring pressure injuries. The patient must not exceed the safe working load as specified by the support surface. A healthcare professional should determine the use...
Source: Medical Device Recalls - September 16, 2018 Category: Medical Devices Source Type: alerts
Intuitive Surgical, Inc. - Intuitive Surgical da Vinci X/Xi EndoWrist 8mm Monopolar Curved Scissors - Class 2 Recall
da Vinci X/Xi EndoWrist 8mm Monopolar Curved Scissors Model No. 470179-14 Product Usage: EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needl...
Source: Medical Device Recalls - September 13, 2018 Category: Medical Devices Source Type: alerts
Intuitive Surgical, Inc. - Intuitive Surgical da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors - Class 2 Recall
da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors Model No. 420179-16 Product Usage: EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needl...
Source: Medical Device Recalls - September 13, 2018 Category: Medical Devices Source Type: alerts
Philips Electronics North America Corporation - Philips SureSigns VSV (Vital Signs Viewer) - Class 2 Recall
Philips SureSigns VS3 Vital Signs Monitor, 863069 863070 863071 863072 863073 863074 The SureSigns VS3 monitor is for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 23, 2018 Category: Medical Devices Source Type: alerts
Philips Electronics North America Corporation - Philips SureSigns VS2 monitor - Class 2 Recall
Philips SureSigns VS2 monitor, 863079 863080 863081 863082 863283 863286 The Sure Signs VS2 vital signs monitor is for use by healthcare professionals whenever there is a need for monitoring the physiological parameter of patients. Standard and optional parameters include: NBP, Sp02, Temperature. The Sure Signs VS2 vital signs monitor is for the monitoring, recording and alarming of multiple parameters of adult, pediatric and neonates in healthcare environments. Additionally, this monitor is intended for transport situations within the healthcare facility. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 23, 2018 Category: Medical Devices Source Type: alerts
Philips Electronics North America Corporation - Philips SureSigns VS4 Vital Signs Monitor - Class 2 Recall
Philips SureSigns VS4 Vital Signs Monitor, 863283 863286 The SureSigns VS4 vital signs monitor is for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS4 monitor is for monitoring, recording, and alarming of multiple physiological parameters in healthcare environments for the patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 23, 2018 Category: Medical Devices Source Type: alerts
