Siemens Medical Solutions USA Inc. - Biograph mCT family - Class 2 Recall
BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10528956 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 16, 2016 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA Inc. - Biograph mCT family - Class 2 Recall
BIOGRAPH mCT S(20) - 4R, MATERIAL NUMBER 10528958 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 16, 2016 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA Inc. - Biograph mCT family - Class 2 Recall
Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 16, 2016 Category: Medical Equipment Source Type: alerts
Leica Biosystems Richmond Inc. - Class 3 Recall
Ariol is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the detection, classification, and counting of cells of interest based on particular color, intensity, size, pattern, and shape. This particular Ariol software application is intended to measure, count, and quantitate the percentage and intensity of positively stained nuclei in formalin-fixed paraffin-embedded tissue specimens immunohistochemically stained for Estrogens Receptors or Progesterone Receptors (ER/PR). ER/PR results are indicated for use as and aid in the management...
Source: Medical Device Recalls - June 11, 2016 Category: Medical Equipment Source Type: alerts
Neusoft Medical Systems Co., Ltd. - CT Scanner - Class 2 Recall
NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i) (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 12, 2016 Category: Medical Equipment Source Type: alerts
Philips and Neusoft Medical Systems Co., Ltd. - NeuViz 16 MultiSlice CT Scanner System - Class 2 Recall
NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 28, 2016 Category: Medical Equipment Source Type: alerts
Roche Molecular Systems, Inc. - Class 2 Recall
Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 28, 2016 Category: Medical Equipment Source Type: alerts
Stryker Instruments Div. of Stryker Corporation - SurgiCounter scanner part of the SurgiCount SafetySponge System - Class 2 Recall
SurgiCounter scanner, part of the SurgiCount Safety-Sponge System. Model numbers 0694-097-000 and 0694-097-001. Product Usage: The SurgiCount Safety Sponge System is indicated for use in counting and recording the number of thermally labeled surgical sponges, laparotomy sponges, and towels used during surgical procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 14, 2016 Category: Medical Equipment Source Type: alerts
Stryker Instruments Div. of Stryker Corporation - SurgiCounterscanner is part of the SurgiCount SafetySponge System. - Class 2 Recall
SurgiCounter" scanner Product Usage: The SurgiCount Safety Sponge System is indicated for use in counting and recording the number of thermally labeled surgical sponges, laparotomy sponges, and towels used during surgical procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 14, 2016 Category: Medical Equipment Source Type: alerts
GE Medical Systems, LLC - GE SIGNA Pioneer - Class 2 Recall
SIGNA Pioneer MR Systems Product Usage: The SIGNA Pioneer 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 bein...
Source: Medical Device Recalls - April 8, 2016 Category: Medical Equipment Source Type: alerts
Wfr/aquaplast Corp - Access ClearVue Prone Breast Device - Class 2 Recall
Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device Product Usage: Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device is a medical charged-particle radiation therapy system. A breast radiation therapy patient support, is an accessory for medical linear accelerator radiation therapy. It may be used with CT and MR scanners to acquire images for radiation therapy planning. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 26, 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
