135 results
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Sources: EU EUDAMED, US FDA
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LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting curve analysis with corresponding assays.
FDA Recall
Terminated
·Roche Molecular Systems, Inc.·Product code NSX·July 16, 2012
SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained,
FDA Recall
Terminated
·Soft Computer Consultants, Inc.·Product code NSX·May 31, 2017
Baxter''s Patient Care System (BPCS) software, composed of Pharmacy Management - Inpatient - product code 2M5013, Point of Care - product code 2M5014 and Management Reports - product code 2M5015; Baxter Healthcare Corporation, 1 Baxter Parkway, Deerfield, IL 60015, USA, made in Canada
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code NSX·June 16, 2005
The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry analyzer. It is intended for in vitro quantitative or qualitative determination of a wide range of analytes in various body fluids.
FDA Recall
Terminated
·Roche Molecular Systems, Inc.·Product code NSX·July 16, 2012
Picis ED PulseCheck-Software, transmission & storage, patient data Service Pack v5.0 L and M This product is a non-alarming software patient information system that compiles an electronic medical record utilizing commonly available hardware. A patient record is populated with information from various sources, such as health care professionals, medical devices connected to the system, and data that arrives via hospital and laboratory information systems. The application stores this information in a database and displays it to healthcare providers in different formats for informational purposes. The product is intended for use by healthcare professionals.
FDA Recall
Terminated
·Picis Inc.·Product code NSX·August 1, 2011
EasyLink(TM) Informatics System, Part Number 1000034805. EasyLink(TM) Informatics System is classified as a data calculator and processing module for use with In-Vitro diagnostics devices.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code NSX·June 7, 2012
Softbank software Product Usage: Decision support software for transfusion service. It keeps track of inventory from outside sources, multi-site inventory control, records of testing of units, and allows for record keeping for transfusion preparation.
FDA Recall
Terminated
·Soft Computer Consultants, Inc.·Product code NSX·October 6, 2016
Software version 4.44A utilized on the BD MAX System
FDA Recall
Terminated
·BD LIFE SCIENCES·Product code NSX·July 29, 2015
syngo(R) Lab Data Manager - Version VA11B and VA12A Systems Securely consolidates data from multiple lab instruments, the LIS and Siemens StreamLAB(R) Automation Solutions. It provides autoverification, integrated QC capabilities, browser-based connectivity supporting up to 25 concurrent users, remote services to help keep systems running optimally and also has audit trail capabilities.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code NSX·May 10, 2013
Philips IntelliVue Clinical Information Portfolio software as follows: 865047 IntelliVue Clinical Information Portfolio Release D.03; 865209 IntelliVue Clinical Information Portfolio Release E.0 and E.01; 865300 IntelliVue Clinical Information Portfolio NICU Link
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code NSX·March 16, 2011
Cisco brand HealthPresence, version 2.1; Model/Catalog Number: CHP-ENTPRSYR2.I-K9; Product is manufactured and distributed by Cisco Systems, Inc. San Jose, CA Cisco HealthPresence, version 2 is intended for remote consultation of patients with a healthcare provider. Cisco HealthPresence enables remote collaboration between a physician and a patient by providing: high-definition video and advanced audio; transmission and display of third-party medical device data; integration with third party EMR: scheduling: and other software applications for remote consultations and exams. Cisco Health Presence is not intended for use in emergency situations. Cisco HealthPresence is not intended for use in active patient monitoring or alarming.
FDA Recall
Terminated
·Cisco Systems Inc·Product code NSX·July 23, 2012
Picis ED Pulsecheck - EMR Software Application - 2125, Software Versions: 5.2 and 5.3. The application stores patient information in a database, and it may analyze and/or display the data in different formats for evaluation by healthcare professionals for informational purposes.
FDA Recall
Terminated
·Picis Inc.·Product code NSX·June 21, 2013
The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for automated isolation of nucleic acids in various types of biological materials. This is a general purpose instrument. There are no corresponding assays.
FDA Recall
Terminated
·Roche Molecular Systems, Inc.·Product code NSX·July 16, 2012
SCC Soft Computer Softbank II software Product Usage: Supports single and multi-site transfusion services in healthcare facilities. Used by healthcare personal to document, query, and view the integrated information regarding patients and products. Quality control testing, test and transfusion history, transfusion management, inventory management, product distribution, and final disposition are all monitored using the software.
FDA Recall
Terminated
·Soft Computer Consultants, Inc.·Product code NSX·October 6, 2016
The COBAS 8000 data manager modular analyzer series (all versions) is a is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in-vitro determinations using a wide variety of tests.
FDA Recall
Terminated
·Roche Molecular Systems, Inc.·Product code NSX·July 16, 2012
DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems and LIS systems.
FDA Recall
Terminated
·Roche Molecular Systems, Inc.·Product code NSX·July 16, 2012
The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with the LightCycler instrument for automated isolation of nucleic acids in various types of biological materials.
FDA Recall
Terminated
·Roche Molecular Systems, Inc.·Product code NSX·July 16, 2012
PICIS, CareSuite Family- OR Manager (4235), Preop Manager (4250), Anesthesia Manager (4220), PACU Manager (4245) & Critical Care Manager (1110), patient information systems.
FDA Recall
Terminated
·Picis Inc.·Product code NSX·April 8, 2009
Picis Anesthesia Manager, PACU Manager,Critical Care Manager-8.2 Service Pack 4 or higher (Software, transmission & storage, patient data) This product is a non-alarming software patient information system that compiles an electronic medical record utilizing commonly available hardware. A patient record is populated with information from various sources, such as health care professionals, medical devices connected to the system, and data that arrives via hospital and laboratory information systems. The application stores this information in a database and displays it to healthcare providers in different formats for informational purposes. The product is intended for use by healthcare professionals.
FDA Recall
Terminated
·Picis Inc.·Product code NSX·August 12, 2011
Siemens syngo(R) Lab Data Manager. The syngo(R) Lab Data Manager is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple interfaced instruments
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code NSX·June 7, 2012