NeuroLogica Corporation - Samsung GM60A40S - Class 2 Recall
Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 11, 2015 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc. - Class 2 Recall
The Siemens Symbia T Series is a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) camera system for nuclear medicine images, and a computed tomography (CT) camera system for x-ray images. Product Usage: Indications for use: The Siemens Symbia T series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer...
Source: Medical Device Recalls - August 21, 2015 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc. - Class 2 Recall
The Siemens Intevo Series system is a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) camera system for nuclear medicine images, and a computed tomography (CT) camera system for x-ray images. Product Usage: Indications for use: The Siemens Symbia T series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and c...
Source: Medical Device Recalls - August 21, 2015 Category: Medical Equipment Source Type: alerts
Hitachi Medical Systems America Inc - Hitachi Oasis MRI Coil Extension Cable - Class 2 Recall
Oasis Coil Extension Cable used with Hitachi Oasis MRI System Product Usage: The Oasis MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The Oasis system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearanc...
Source: Medical Device Recalls - August 11, 2015 Category: Medical Equipment Source Type: alerts
TITAN SPINE, LLC - Endoskeleton Locking Bone Screw Assembly - Class 2 Recall
Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TCS Interbody Fusion Device. Part Numbers / Product Description: 5302-3514 / 03.5 x 14mm Locking Screws; 5302-3516 / 03.5 x 16mm Locking Screws; 502-3518 / 03.5 x 18mm Locking Screws; 5302-3814 / 03.8 x 14mm Locking Screws; 5302-3816 / 03.8 x 16 mm Locking Screws; 5302-3818 / 03.8 x 18mm Locking Screws. The Endoskeleton¿ TCS Interbody Fusion Device (IBD) implants are available in a variety of sizes with a variety of lordotic angles, to accommodate patient anatomy. Endoskeleton¿ TCS IBD implants are intended for...
Source: Medical Device Recalls - August 4, 2015 Category: Medical Equipment Source Type: alerts
GE Healthcare - GE Healthcare Innova IGS 530 - Class 2 Recall
GE Healthcare Innova IGS 530. 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 nonvascular, 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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 4, 2015 Category: Medical Equipment Source Type: alerts
GE Healthcare - GE Healthcare Innova IGS 520 - Class 2 Recall
GE Healthcare Innova IGS 520. 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 nonvascular, 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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 4, 2015 Category: Medical Equipment Source Type: alerts
GE Healthcare - GE Healthcare Innova 2100IQ - Class 2 Recall
GE Healthcare Innova 2100IQ 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 nonvascular, 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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 4, 2015 Category: Medical Equipment Source Type: alerts
GE Healthcare - GE Healthcare Discovery IGS 730 - Class 2 Recall
GE Healthcare Discovery IGS 730. 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 nonvascular, 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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 4, 2015 Category: Medical Equipment Source Type: alerts
GE Healthcare - GE Healthcare Innova 3131IQ - Class 2 Recall
GE Healthcare Innova 3131IQ 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 nonvascular, 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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 4, 2015 Category: Medical Equipment Source Type: alerts
GE Healthcare - GE Healthcare Innova IGS 630 - Class 2 Recall
GE Healthcare Innova IGS 630. 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 nonvascular, 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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 4, 2015 Category: Medical Equipment Source Type: alerts
GE Healthcare - GE Healthcare Optima IGS 320 - Class 2 Recall
GE Healthcare Optima IGS 320. 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 nonvascular, 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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 4, 2015 Category: Medical Equipment Source Type: alerts
GE Healthcare - GE Healthcare Optima CL 323i - Class 2 Recall
GE Healthcare Optima CL 323i. 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 nonvascular, 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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 4, 2015 Category: Medical Equipment Source Type: alerts
GE Healthcare - GE Healthcare Innova 3100IQ - Class 2 Recall
GE Healthcare Innova 3100IQ 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 nonvascular, 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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 4, 2015 Category: Medical Equipment Source Type: alerts
GE Healthcare - GE Healthcare Innova IGS 540 - Class 2 Recall
GE Healthcare Innova IGS 540. 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 nonvascular, 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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 4, 2015 Category: Medical Equipment Source Type: alerts
