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This page shows you the most recent publications within this specialty of the MedWorm directory. This is page number 6.

Vapotherm, Inc. - Class 2 Recall
Vapotherm Precision Flow,Disposable Patient Circuit PF-NODPC-Low. For use with the Precision Flow system and Ikaria INOmax DSIR ¿ System. This DPC allows clinicians to administer nitric oxide non-invasively via high flow nasal cannula. In the Precision Flow High Flow Therapy application, a special disposable patient circuit re-routes the gas to the INOmax injector module then back into the Precision Flow system (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 26, 2014 Category: Medical Equipment Source Type: alerts

Vapotherm, Inc. - Class 2 Recall
Vapotherm Precision Flow,Disposable Patient Circuit PFHDPC-Low. For use with the Heliox Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 26, 2014 Category: Medical Equipment Source Type: alerts

Vapotherm, Inc. - Class 2 Recall
Vapotherm Precision Flow,Disposable Patient Circuit PF-DPC-Low. For use with the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 26, 2014 Category: Medical Equipment Source Type: alerts

Vapotherm, Inc. - Class 2 Recall
Vapotherm Precision Flow,Disposable Patient Circuit PFNODPC-High. For use with the Precision Flow system and Ikaria INOmax DSIR ¿ System. This DPC allows clinicians to administer nitric oxide non-invasively via high flow nasal cannula. In the Precision Flow High Flow Therapy application, a special disposable patient circuit re-routes the gas to the INOmax injector module then back into the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute instituti...
Source: Medical Device Recalls - September 26, 2014 Category: Medical Equipment Source Type: alerts

Vapotherm, Inc. - Class 2 Recall
Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-High. For use with the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 26, 2014 Category: Medical Equipment Source Type: alerts

Argon Medical Devices, Inc - UltraStream Exchange Kit - Class 2 Recall
The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 25, 2014 Category: Medical Equipment Source Type: alerts

Argon Medical Devices, Inc - UltraStream Chronic Hemodialysis Catheter - Class 2 Recall
The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 25, 2014 Category: Medical Equipment Source Type: alerts

Argon Medical Devices, Inc - UltraStream Peel Away Kit - Class 2 Recall
UltraStream Peel Away Kit The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 25, 2014 Category: Medical Equipment Source Type: alerts

Pdg Product Design Group Inc - Fuze Manual Tilt Wheelchair - Class 2 Recall
No packaging. Device is a wheel chair. Fuze T50, Fuze T20 and Fuze T50 Jr (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 25, 2014 Category: Medical Equipment Source Type: alerts

ARJOHUNTLEIGH POLSKA Sp. z.o.o. - Class 2 Recall
Minstrel (with scale) Product Usage: is a mobile passive hoist. It is intended for lifting and transporting adult residents on horizontal floors in hospitals, nursing homes or other health care facilitates. The Minstrel device aids in the lifting, transfer and lowering to safe position, of a patient. This is accomplished by placing a sling under the patient, and attaching the sling to a spreader bar that is connected to a lifting arm jig via a connection to the spreader bar that allows a swiveling up-down movement. Using battery power, an actuator then powers the lifting arm upwards so that the patient in the sling is lif...
Source: Medical Device Recalls - September 25, 2014 Category: Medical Equipment Source Type: alerts

Alcon Research, Ltd. - eyepak Tray Support Cover - Class 2 Recall
eye-pak 7407 Tray Support Cover REF 8065740745 (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 25, 2014 Category: Medical Equipment Source Type: alerts

Horiba Instruments, Inc dba Horiba Medical - ABX PENTRA Magnesium RTU - Class 2 Recall
ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646 Product Usage: ABX PENTRA Magnesium RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of magnesium in human serum and plasma based on a photometric test using xylidyl blue. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemnia (abnormally low plasma levels of magnesium) and hypermagnesemnia (abnormally high plasma levels of magnesium). (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 25, 2014 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - Siemens AXIOM Artis or Artis zee system - Class 2 Recall
AXIOM Artis or Artis zee system Product Usage: Axiom Artis and Artis zee / zeego are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 25, 2014 Category: Medical Equipment Source Type: alerts

Nanosphere, Inc. - Class 2 Recall
The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection (BSI). BC-UP is performed directly on blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-positive bacteria. BC-UP detects and identifies the following bacterial genera and species: Staphylococcus spp., Staphylococcus aureus, Staphylococcus epidermidis, ...
Source: Medical Device Recalls - September 24, 2014 Category: Medical Equipment Source Type: alerts

Nanosphere, Inc. - Class 2 Recall
The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with signs and symptoms of respiratory tract infection. The following virus types and subtypes are identified using the RV+: Influenza A, Influenza A subtype H1, Influenza A subtype H3, 2009 H1N1, Influenza B, Respiratory Syncytial Virus (RSV) subtype A, and RSV subtype B. The test is not intended to detect Influenza C virus. Detecting and identifying speci...
Source: Medical Device Recalls - September 24, 2014 Category: Medical Equipment Source Type: alerts

Nanosphere, Inc. - Class 2 Recall
The Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers. BC-GN is performed directly on blood culture media using blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram negative bacteria as determined by gram stain. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 24, 2014 Category: Medical Equipment Source Type: alerts

Smith & Nephew, Inc. - RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) - Class 2 Recall
RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction device particulary as the device may promote wound healing. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 24, 2014 Category: Medical Equipment Source Type: alerts

Nanosphere, Inc. - Class 2 Recall
The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic strains Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). Presumptive identification of the PCR ribotype 027 strain of C. difficile is by detection of the binary toxin (cdt) gene sequence and the single base pair deletion at nucleotide 117 in the tcdC gene. The tc...
Source: Medical Device Recalls - September 24, 2014 Category: Medical Equipment Source Type: alerts

Beckman Coulter Inc. - UniCel Access Immunoassay Systems - Class 2 Recall
UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids. The cables and kits are used in UniCel DxI 600, 800 instruments, and are distributed to Beckman and Non-Beckman Service Engineers for replacement of worn and/or damaged parts during field services calls. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 24, 2014 Category: Medical Equipment Source Type: alerts

Nanosphere, Inc. - Class 2 Recall
The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection (BSI). BC-UP is performed directly on blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-positive bacteria. BC-UP detects and identifies the following bacterial genera and species: Staphylococcus spp., Staphylococcus aureus, Staphylococcus epidermidis, ...
Source: Medical Device Recalls - September 24, 2014 Category: Medical Equipment Source Type: alerts

Smith & Nephew, Inc. - RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) - Class 2 Recall
RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction device particulary as the device may promote wound healing. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 24, 2014 Category: Medical Equipment Source Type: alerts

Nanosphere, Inc. - Class 2 Recall
The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria and genetic virulence markers from liquid or soft stool preserved in Cary-Blair media, collected from individuals with signs and symptoms of gastrointestinal infection. The test is performed on the automated Nanosphere Verigene System utilizing reverse transcription (RT), polymerase chain reaction (PCR), and array hybridization to detect specific gastrointestinal microbial nucleic acid gene sequences associated with the following pathogenic bacteria: -...
Source: Medical Device Recalls - September 24, 2014 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - The Ysio Systems with software version VC10 - Class 2 Recall
The Ysio Systems with software version VC10 The Ysio enables radiographic and tomographic exposures of the whole Body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 24, 2014 Category: Medical Equipment Source Type: alerts

Carefusion 2200 Inc - Class 2 Recall
CareFusion AirLife Heated Infant Breathing Circuit Product Usage: Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 24, 2014 Category: Medical Equipment Source Type: alerts

Justright Surgical, LLC - JustRight 5mm Reload - Class 2 Recall
Justright Surgical, JustRight 5mm Reload, REFJR-REL25-2.0, Sterile, EO, Rx Only It is a replacement cartridge used when more than one firing is required during a surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 24, 2014 Category: Medical Equipment Source Type: alerts

Justright Surgical, LLC - JustRight 5mm Stapler - Class 2 Recall
Justright Surgical, JustRight 5mm Stapler, REF JR-ST25-2.0, Sterile, EO, Rx Only, JR-ST25-2.0 product is packaged in cases of 6. The JustRight 5mm Stapler is intended for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomosis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 24, 2014 Category: Medical Equipment Source Type: alerts

Justright Surgical, LLC - JustRight 5mm Reload - Class 2 Recall
Justright Surgical, JustRight 5mm Reload, REFJR-REL25-2.0, Sterile, EO, Rx Only It is a replacement cartridge used when more than one firing is required during a surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 24, 2014 Category: Medical Equipment Source Type: alerts

Fresenius Medical Care Holdings, Inc. - Fresenius Medical Naturalyte Liquid Bicarbonate Concentrate - Class 2 Recall
Fresenius Naturalyte Liquid Bicarbonate Concentrate Product Number: 08-4000-LB The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 24, 2014 Category: Medical Equipment Source Type: alerts

Justright Surgical, LLC - JustRight 5mm Stapler - Class 2 Recall
Justright Surgical, JustRight 5mm Stapler, REF JR-ST25-2.0, Sterile, EO, Rx Only, JR-ST25-2.0 product is packaged in cases of 6. The JustRight 5mm Stapler is intended for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomosis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 24, 2014 Category: Medical Equipment Source Type: alerts