Roche Diagnostics Hematology - cobas m 511 integrated hematology analyzer - Class 2 Recall
cobas m 511 integrated hematology analyzer, Model Number 07261691190 Product Usage: The cobas m 511 integrated hematology analyzer is a quantitative, automated analyzer with cell locating capability. It is intended for in vitro diagnostic use by a skilled operator in the clinical laboratory. The system prepares a stained microscope slide from EDTA anticoagulated whole blood. It utilizes computer imaging to count the formed elements of blood and provide an image-based assessment of cell morphology, which may be reviewed by the operator, and also allows for manual classification of unclassified cells. The instrument reports...
Source: Medical Device Recalls - July 27, 2018 Category: Medical Devices Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Philips IQon Spectral CT with softare version 4.7 - Class 2 Recall
IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 3, 2018 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc. - Biograph mCT Systems: - Class 2 Recall
Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 Product Usage: The Siemens Biograph mCT and Biograph mCT Flow 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. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceutical...
Source: Medical Device Recalls - June 9, 2018 Category: Medical Devices Source Type: alerts
MEDTECH SAS - ROSA(TM) Robotized Stereotactic Assistant - Class 2 Recall
ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 8, 2018 Category: Medical Devices Source Type: alerts
GE Healthcare - Centricity PACSIW with Universal Viewer - Class 2 Recall
Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specificatio...
Source: Medical Device Recalls - June 7, 2018 Category: Medical Devices Source Type: alerts
GE Healthcare - Centricity Universal Viewer - Class 2 Recall
Centricity Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed a...
Source: Medical Device Recalls - June 7, 2018 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - SOMATOM Emotion (2003) - Class 2 Recall
SOMATOM Emotion (2003) Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 1, 2018 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - SOMATOM Emotion 16 - Class 2 Recall
SOMATOM Emotion 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 1, 2018 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - SOMATOM Perspective - Class 2 Recall
SOMATOM Perspective Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 1, 2018 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - SOMATOM Scope Power - Class 2 Recall
SOMATOM Scope Power Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 1, 2018 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - SOMATOM Spirit - Class 2 Recall
SOMATOM Spirit Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 1, 2018 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - SOMATOM Sensation 10 - Class 2 Recall
SOMATOM Sensation 10 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 1, 2018 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - SOMATOM Sensation 40 - Class 2 Recall
SOMATOM Sensation 40 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 1, 2018 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - SOMATOM Scope - Class 2 Recall
SOMATOM Scope Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 1, 2018 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - SOMATOM Emotion Duo (2003) - Class 2 Recall
SOMATOM Emotion Duo (2003) Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 1, 2018 Category: Medical Devices Source Type: alerts
