Baxter Healthcare Corporation - Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6 and Version 8) - Class 2 Recall
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), infusion pump, 35700BAX2 Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixture of required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluid space. Spectrum Infusion Pump is intended to be used in conjunction with legally marketed intraveno...
Source: Medical Device Recalls - June 8, 2018 Category: Medical Devices Source Type: alerts
Baxter Healthcare Corporation - Sigma Spectrum Infusion Pump with master Drug Library Version 6. - Class 2 Recall
Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAXL Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration se...
Source: Medical Device Recalls - May 5, 2018 Category: Medical Devices Source Type: alerts
Baxter Healthcare Corporation - Sigma Spectrum Infusion Pump with master Drug Library Version 6. - Class 2 Recall
Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXR Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration se...
Source: Medical Device Recalls - May 5, 2018 Category: Medical Devices Source Type: alerts
Baxter Healthcare Corporation - Sigma Spectrum Infusion Pump with master Drug Library Version 6. - Class 2 Recall
Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRE Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration s...
Source: Medical Device Recalls - May 5, 2018 Category: Medical Devices Source Type: alerts
Baxter Healthcare Corporation - Sigma Spectrum Infusion Pump with master Drug Library Version 6. - Class 2 Recall
Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRP Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration s...
Source: Medical Device Recalls - May 5, 2018 Category: Medical Devices Source Type: alerts
Baxter Healthcare Corporation - Sigma Spectrum Infusion Pump with master Drug Library Version 6. - Class 2 Recall
Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration set...
Source: Medical Device Recalls - May 5, 2018 Category: Medical Devices Source Type: alerts
Baxter Healthcare Corporation - Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Class 2 Recall
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570); Model Numbers: 35700BAX and 35700ABB. Intended to be used for the controlled administration of fluids. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 13, 2018 Category: Medical Devices Source Type: alerts
Philips Electronics North America Corporation - PIIC iX Intellivue iX Information Center Software - Class 2 Recall
Intellivue iX Information Center Software - All PIIC iX Surveillance stations including: 866023 IntelliVue Info Center iX A.0 866117 PIIC Classic Upgrade 866389 IntelliVue Info Center iX B.0, C.0 867141 IntelliVue Info Center iX B.0 866025 IntelliVue Server IX A.0 866118 Database Server Upgrade A.0 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 1, 2018 Category: Medical Devices Source Type: alerts
Optovue, Inc. - Optical Coherence Tomography System - Class 2 Recall
iVue 500 with iScan, D216606. Product non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue 500 with normative database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue 500 with normative database is indicated ...
Source: Medical Device Recalls - October 5, 2017 Category: Medical Devices Source Type: alerts
Optovue, Inc. - Optical Coherence Tomography System - Class 2 Recall
iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions. The iCam takes digital images of the posterior and external structures of the eye without the use of a mydriatic agent and is intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health. iCam provides images only and does not provide any diagnostic, pathological analysis or classification of ocular heal...
Source: Medical Device Recalls - October 5, 2017 Category: Medical Devices Source Type: alerts
Optovue, Inc. - Optical Coherence Tomography System - Class 2 Recall
iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional, and three dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal s...
Source: Medical Device Recalls - October 5, 2017 Category: Medical Devices Source Type: alerts
Baxter Healthcare Corporation - Baxter SIGMA Spectrum Infusion Pump with Master Drug Library - Class 2 Recall
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2 (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 3, 2017 Category: Medical Devices Source Type: alerts
Merge Healthcare, Inc. - Merge Eye Care PACS Viewer 5.2 - Class 2 Recall
Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the display, management, archive, interface and integration of ophthalmic device reports, images and data. Merge Eye Care PACS is a software solution using databases for patient demographics, server and other systems of intercommunication with hospital systems via HL7 and DICOM to provide to clinicians a single image viewing and management solution of images imported from various contributing devices throughout the clinical environment. Merge Eye Care PACS provides the ability to review data from any network-connected computer, and is protected ...
Source: Medical Device Recalls - July 11, 2017 Category: Medical Devices Source Type: alerts
AGFA Healthcare Corp. - Agfa IMPAX Cardiovascular - Class 2 Recall
IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with representation in printed or electronic formats (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 30, 2017 Category: Medical Devices Source Type: alerts
Philips Electronics North America Corporation - Class 2 Recall
M3150 Information Center Local Database; Models: 862249, 865001, 865003, 865004, 865007, 865009, 865011, 865012, 865091, 865092, 865093, 865094, 865095, 865096, 865098, 865099, 865102, 865104, 865105, 865125, 865127. The intended use of the Information Center Software is to display physiologic waves, parameters and trends, formal data for strip recordings and printed reports and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An add...
Source: Medical Device Recalls - June 14, 2017 Category: Medical Devices Source Type: alerts
