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

Phillips Respironics, Inc. - Philips Respironics Trilogy 100, Trilogy 200, Trilogy 202 - Class 1 Recall
Trilogy Ventilators The Respironics Trilogy 100 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator. Trilogy 200 Intended Use: The Respironics Trilogy 200 system provides continuous or intermittent ventilator support ...
Source: Medical Device Recalls - March 7, 2014 Category: Medical Equipment Source Type: alerts

Elekta, Inc. - Desktop Pro TM and Desktop Pro (VMAT) - Class 2 Recall
Desktop Pro TM linear accelerator control software intended to assist a licensed practitioner in the delivery of radiation to defined target volumes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 7, 2014 Category: Medical Equipment Source Type: alerts

Greatbatch Medical - Offset Cup Impactor - Class 1 Recall
Greatbatch Medical, Offset Cup Impactor. The Standard Offset Cup Impactor is a reusable instrument used during acetabular replacement surgery to implant an acetabular cup. The Standard Offset Cup Impactor is provided non-sterile and must be sterilized prior to use in a surgery. The Standard Offset Cup Impactor is used to implant cups during many minimally invasive surgical approaches to Total Hip Arthroplasty ( ri-IA). (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 7, 2014 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - GSI Viewer - Class 2 Recall
GE Healthcare, Model Number/ Description: 5342114 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-2 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-3 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-4 GSI Viewer 1.11 on AW VolumeShare 4 (AW 4.5); 5401757 GSI Viewer 1.20 on AW VolumeShare 3 (AW4.4). Computed Tomography X-Ray system (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 7, 2014 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 - Class 2 Recall
GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the Automatic-View-On- Alarm (AVOA) feature enabled. The Solar 8000i with Patient Data Module / Transport Pro with Patient Data Module is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional medical facility, such as hospital, clinic, surgical center or doctor's office. It can be used in multiple areas such as operating room (OR), post anesthesia care unit (PACU), emergency department (ED), chest pain clinic, general i...
Source: Medical Device Recalls - March 7, 2014 Category: Medical Equipment Source Type: alerts

Elekta, Inc. - Multilead Collimator - Class 2 Recall
Agility. Version 3.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 7, 2014 Category: Medical Equipment Source Type: alerts

Elekta, Inc. - Integrity - Class 2 Recall
Integrity. Version 1.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 7, 2014 Category: Medical Equipment Source Type: alerts

Elekta, Inc. - Multilead Collimator - Class 2 Recall
Agility. Version 3.0 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 7, 2014 Category: Medical Equipment Source Type: alerts

Medefil Incorporated - Heparin I.V. Flush Syringe - Class 3 Recall
Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100 units/mL, 3 mL fill in a 12 mL syringe. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 7, 2014 Category: Medical Equipment Source Type: alerts

Elekta, Inc. - RT Desktop - Class 2 Recall
RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to be used as the user interface for the SL/SLi Series Linear Accelerators that are used for the radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 7, 2014 Category: Medical Equipment Source Type: alerts

Hospira Inc. - LifeShield LatexFree HEMA YType Blood Set IV Administration Set - Class 2 Recall
*** 1) List number 126970465 labeled in part: 12697-65 LifeShield LATEX-FREE HEMA; Y-TYPE BLOOD SET, Nonvented, 88 Inch with 210 Micron Filter Pump, Prepierced Injection Site and Secure Lock; Made in Costa Rica; Product Inquiries should be directed to Hospira, Inc., Lake Forest, IL 60045 USA; *** 2) List Number 127200465 labeled in part: 12720-65 LifeShield LATEX-FREE HEMA; BLOOD SET, Nonvented, 81 Inch with 170 Micron Filter, Pump, Prepierced Injection Site and Secure Lock; Made in Costa Rica; Product Inquiries should be directed to Hospira, Inc., Lake Forest, IL 60045 USA; *** 3) List Number 046419701 labeled in part...
Source: Medical Device Recalls - March 7, 2014 Category: Medical Equipment Source Type: alerts

Toshiba American Medical Systems Inc - CT system - Class 2 Recall
TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 7, 2014 Category: Medical Equipment Source Type: alerts

MCKESSON TECHNOLOGIES INC. - McKesson Anesthesia Care System - Class 1 Recall
McKesson Anesthesia Care Product Usage: The McKesson Anesthesia Care system is a computer based system which collects, processes,and records data both through manual entry and from monitors which themselves are attached to patients, such as in the operating room environment. The system provides clinical decision support by communicating potential Adverse Drug Event alerts proactively during the pre-anesthesia evaluation and at the point-of-care. The system is generally indicated in the anesthetizing environment when the anesthesia provider decides to perform a patient assessment, to generate a paper and/or electronic reco...
Source: Medical Device Recalls - March 6, 2014 Category: Medical Equipment Source Type: alerts

Focus Diagnostics Inc - Simplexa Flu A/B &38; RSV Direct assay - Class 2 Recall
Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C. Model Number MOL2650. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 6, 2014 Category: Medical Equipment Source Type: alerts

KCI USA, INC. - PRE1055: Prevena Dressing, 5 Pack - Class 2 Recall
PRE1055: Prevena Dressing, 5 Pack Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 6, 2014 Category: Medical Equipment Source Type: alerts

KCI USA, INC. - PRE1001: Prevena Peel and Place System Kit - Class 2 Recall
PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 6, 2014 Category: Medical Equipment Source Type: alerts

KCI USA, INC. - PRE1055US: Prevena Dressing, 5 Pack (USONLY) - Class 2 Recall
PRE1055US: Prevena Dressing, 5 Pack (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 6, 2014 Category: Medical Equipment Source Type: alerts

KCI USA, INC. - PRE1001US: Prevena Peel and Place System Kit (USONLY) - Class 2 Recall
PRE1001US: Prevena Peel and Place System Kit (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 6, 2014 Category: Medical Equipment Source Type: alerts

KCI USA, INC. - PRE2055US: Prevena Customizable Dressing 5Pack (USONLY) - Class 2 Recall
PRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 6, 2014 Category: Medical Equipment Source Type: alerts

KCI USA, INC. - PRE2001: Prevena Incision Management Customizable System Box - Class 2 Recall
PRE2001: Prevena Incision Management Customizable System Box Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 6, 2014 Category: Medical Equipment Source Type: alerts

KCI USA, INC. - PRE2055: Prevena Customizable Dressing 5Pack - Class 2 Recall
PRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 6, 2014 Category: Medical Equipment Source Type: alerts

KCI USA, INC. - PRE2001US: Prevena Incision Management Customizable System Box (USONLY) - Class 2 Recall
PRE2001US: Prevena Incision Management Customizable System Box (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 6, 2014 Category: Medical Equipment Source Type: alerts

Horiba Instruments, Inc dba Horiba Medical - ABX PENTRA Multical. ABX PENTRA N Control ABX PENTRA P Control - Class 2 Recall
ABX PENTRA Multical. ABX PENTRA N Control. ABX PENTRA P Control. The ABX PENTRA 400 and PC200 are benchtop clinical chemistry analyzers using two measuring principals: absorbance and ion selective electrodes. The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical additives and materials of biological origin. The assigned values of the calibrator components are given in the enclosed annex, ensuring optimal calibration of the appropriate HORIBA ABX SAS methods on the ABX PENTRA Clinical Chemistry Analyzer. This calibrator is provided in ten vials of 3 ml. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 6, 2014 Category: Medical Equipment Source Type: alerts

AlterG, Incorporated - AlterG AntiGravity Treadmill - Class 2 Recall
Accessory shorts for the AlterG Anti-Gravity treadmill. Use with the AlterG Anti-Gravity Treadmill for rehabilitation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 5, 2014 Category: Medical Equipment Source Type: alerts

Synthes, Inc. - Synthes 5.0mm Variable Locking Screw - Class 2 Recall
Synthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking Compression Plate family and this technology included variable angle Combi holes in the plate shaft.The variable angle Combi hole provides the flexibility of axial compression and variable locking capacity throughout the length of the plate shaft. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 5, 2014 Category: Medical Equipment Source Type: alerts