Medtronic Navigation, Inc. - Medtronic Oarm O2 Imaging System - Class 2 Recall
Medtronic 0-arm 02 Imaging System Catalog Number: Bl-700-02000 The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The O-arm O2 Imaging System is compatible with certain image guided surgery systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 9, 2016 Category: Medical Equipment Source Type: alerts
GE Medical Systems, LLC - GE PET/CT System - Class 2 Recall
LightSpeed 16 (MDAS only , , 2339985 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiolo...
Source: Medical Device Recalls - March 5, 2016 Category: Medical Equipment Source Type: alerts
GE Medical Systems, LLC - GE PET/CT System - Class 2 Recall
Discovery LS, 2286327 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions....
Source: Medical Device Recalls - March 5, 2016 Category: Medical Equipment Source Type: alerts
GE Medical Systems, LLC - GE PET/CT System - Class 2 Recall
LightSpeed Ultra (8-slice MDAS), 5120327-3 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and p...
Source: Medical Device Recalls - March 5, 2016 Category: Medical Equipment Source Type: alerts
GE Medical Systems, LLC - GE PET/CT System - Class 2 Recall
Discovery ST, , 2339985 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions....
Source: Medical Device Recalls - March 5, 2016 Category: Medical Equipment Source Type: alerts
GE Medical Systems, LLC - GE PET/CT System - Class 2 Recall
LightSpeed Plus (4-slice MDAS LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic func...
Source: Medical Device Recalls - March 5, 2016 Category: Medical Equipment Source Type: alerts
GE Medical Systems, LLC - GE PET/CT System - Class 2 Recall
LightSpeed QX/I (4-slice MDAS) LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic f...
Source: Medical Device Recalls - March 5, 2016 Category: Medical Equipment Source Type: alerts
Zimmer Biomet, Inc. - ZIMMER UNICOMPARTMENTAL KNEE SYSTEM - Class 2 Recall
ZIMMER UNI HIGH FLEX PRECOAT FEM prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer various sizes These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. " These devices are indicated for cemented use only. " The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees." (Source:...
Source: Medical Device Recalls - February 23, 2016 Category: Medical Equipment Source Type: alerts
NORTHSIDE HOSPITAL AMENITY KIT (Alcohol And Sodium Monofluorophospate) Kit [Anatomy Supply Partners, LLc]
Updated Date: Jan 21, 2016 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - January 21, 2016 Category: Drugs & Pharmacology Source Type: alerts
NORTHSIDE HOSPITAL AMENITY KIT--GI DEPT (Alcohol) Kit [Anatomy Supply Partners, LLc]
Updated Date: Jan 20, 2016 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - January 20, 2016 Category: Drugs & Pharmacology Source Type: alerts
INSTANT HAND ANTISEPTIC (Ethyl Alcohol) Gel [Anatomy Supply Partners, LLc]
Updated Date: Jan 12, 2016 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - January 12, 2016 Category: Drugs & Pharmacology Source Type: alerts
INSTANT HAND ANTISEPTIC (Ethyl Alcohol) Gel [Anatomy Supply Partners, LLc]
Updated Date: Dec 18, 2015 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))
Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) - December 18, 2015 Category: Drugs & Pharmacology Source Type: alerts
GE Medical Systems, LLC - Optima CL323i - Class 2 Recall
GE Healthcare Optima CL323i Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures. The OR table is suitable for interventional and surgical procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 13, 2015 Category: Medical Equipment Source Type: alerts
GE Medical Systems, LLC - Optima IGS 320 - Class 2 Recall
GE Healthcare Optima IGS 320. Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures. The OR table is suitable for interventional and surgical procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 13, 2015 Category: Medical Equipment Source Type: alerts
Philips Electronics North America Corporation - Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1 - Class 2 Recall
Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1 Product Usage: The DigitalDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctors or technicians. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 11, 2015 Category: Medical Equipment Source Type: alerts
