Becton Dickinson & Co. - EpiCenter Plus Microbiology Data Management System - Class 2 Recall
EpiCenter Plus Microbiology Data Management System software version 6.20A, when used in conjunction with the MALDI BioTyper System . Product Usage: The EpiCenter system is a clinical data management system designed for use with certain BD instrument systems. The EpiCenter system provides advanced capabilities in data management, including extended demographic data, comprehensive reporting features including a powerful database query tool, bi-directional Laboratory Information System (LIS) communications and long-term data storage. Additionally, the EpiCenter system provides an Expert System that can manipulate and/or act ...
Source: Medical Device Recalls - February 28, 2017 Category: Medical Equipment Source Type: alerts
Baxter Healthcare Corp. - sigmaspectrum VOLUMETRIC INFUSION PUMP with Master Drug Library - Class 2 Recall
sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum Infusion Pump, Product Code 35700BAX and 35700BAXR, Unique Device Identifier GTIN 00085412091570, Rx ONLY -- Sigma, LLC Medina, NY 14103 --- NOTE: The speakers are a part of the rear case assembly located in the back of the infusion pump. The speaker is intended to generate audible tones during each keystroke, and during alarm conditions. However, some speakers have a variation in their internal wiring that increases the potential for the speaker to fail prematurely. Spectrum Infusion Pumps with non-functional speakers will continue to display vi...
Source: Medical Device Recalls - November 30, 2016 Category: Medical Equipment Source Type: alerts
Baxter Healthcare Corp. - SIGMA Spectrum INFUSION PUMP with Master Drug Library - Class 2 Recall
Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum Infusion Pump, Product Code 35700BAX2, Unique Device Identifier GTIN 00085412091570, Rx ONLY -- Baxter Healthcare Corporation, Medina, NY 14103 --- NOTE: The speakers are a part of the rear case assembly located in the back of the infusion pump. The speaker is intended to generate audible tones during each keystroke, and during alarm conditions. However, some speakers have a variation in their internal wiring that increases the potential for the speaker to fail prematurely. Spectrum Infusion Pumps with non-functional speakers will continue to display...
Source: Medical Device Recalls - November 30, 2016 Category: Medical Equipment Source Type: alerts
Siemens Healthcare Diagnostics, Inc - Siemens ADVIA Centaur CA 199 Assay (250 test kit) - Class 2 Recall
ADVIA Centaur CA 19-9 Assay (250 test kit)-for use,with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems. Siemens Material Number(SMN): 10491244 In the 510(k) database the CA 19-9 assay is not CLIA categorized on the ADVIA Centaur XPT instrument. Siemens stated that the assay is being marketed on the XPT following FDA s Reagent Replacement Policy. Siemens plans to request CLIA Categorization for the CA19-9 assay on XPT the week of 11/21/2016. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 18, 2016 Category: Medical Equipment Source Type: alerts
Siemens Healthcare Diagnostics, Inc - Siemens ADVIA Centaur CA 199 Assay (50 test kit) - Class 2 Recall
ADVIA Centaur CA 19-9 Assay (50 test kit)-for use, with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems. Siemens Material Number(SMN): 10491379 In the 510(k) database the CA 19-9 assay is not CLIA categorized on the ADVIA Centaur XPT instrument. Siemens stated that the assay is being marketed on the XPT following FDA s Reagent Replacement Policy. Siemens plans to request CLIA Categorization for the CA19-9 assay on XPT the week of 11/21/2016. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 18, 2016 Category: Medical Equipment Source Type: alerts
Hospira Inc. - Hospira, Inc. - Class 2 Recall
The Plum 360 is a large volume infuser capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions. The Plum 360 infuser can deliver fluids over a broad range of infusion rates and is capable of Concurrent delivery from one or more rigid or flexible fluid containers. The Plum 360 infuser features Concurrent, Secondary, and Piggyback infusions. A positive valving cassette allows two lines to be delivered at independent rates. The volume to be infused (VTBI) is delivered through one line to a patient. The two lines can be delivered in Concurrent mode (together) or Piggyback mod...
Source: Medical Device Recalls - June 4, 2016 Category: Medical Equipment Source Type: alerts
Hospira Inc. - Hospira, Inc. - Class 2 Recall
The Plum A+ is a dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With its primary line, secondary line, and piggyback fluid delivery capability, the Plum A+ is suited for a wide range of medical/surgical and critical care applications. Full compatibility with LifeCare Plum Series administration sets and accessories. Each system includes a pumping module (hereafter called the infuser) and an assortment of disposable IV sets (hereafter called a set), and optional accessories. The Plum A+ host device contains a Conn...
Source: Medical Device Recalls - June 4, 2016 Category: Medical Equipment Source Type: alerts
Eos Imaging Inc - EOS system - Class 2 Recall
EQS is a digital radiography system in which two sets of xenon gas filled digital detectors and X-ray tubes are positioned orthogonally to generate frontal and lateral images simultaneously by scanning the patient over the area of interest. The diagnostic images are stored in a local database and are displayed on a high-resolution, medical-quality monitor, where the diagnosis is performed, The diagnostic image can be transmitted through a DICOM 3.0 compatible digital network for printing and archiving. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 6, 2015 Category: Medical Equipment Source Type: alerts
Baxter Healthcare Corp - Master Drug Library to be used with SIGMA Spectrum Infusion Pump - Class 2 Recall
Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum Infusion System (Pump) version 8.0, Product Code 35700BAX2 The SIGMA Spectrum Infusion Pump with Master Drug Library (MDL) is intended to be used for the controlled administration of fluids. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 17, 2015 Category: Medical Equipment Source Type: alerts
Medtronic MiniMed Inc. - Medtronic MiniMed CareLink Pro 4.0 and Clinical - Class 3 Recall
CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software application designed to enhance Health Care Provider management of diabetic patients using Medtronic insulin pumps and blood glucose meters. MMT-7335 is intended for use by Health Care Providers/Physicians as a therapy management accessory to: - read and store history and settings data supported insulin pump models and supported blood glucose meters - read and report user-programmable settings on supported pump models - read device data from the CareLink Online system - write new device data to the CareLink system - generate reports from th...
Source: Medical Device Recalls - March 3, 2015 Category: Medical Equipment Source Type: alerts
Illumina Inc - MiSeqDx Universal Kit 1.0 - Class 2 Recall
Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Universal Kit 1.0 is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in the subsequent targeted sequencing of the resulting sample libraries. User-supplied analyte specific reagents are required for the preparation of libraries targeting specific genomic regions of interest. The MiSeqDx Universal Kit 1.0 is intended for use with the MiSeqDx instrument. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 24, 2014 Category: Medical Equipment Source Type: alerts
Smiths Medical ASD, Inc. - CADDSolis Medication Safety Software - Class 2 Recall
CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01. Product Usage: The CADD-Solis Medication Safety Software- Administrator allows use of a computer to create therapy-based protocol libraries to be used with the CADD-Solis VIP Ambulatory Infusion Pump, CADD-Solis Ambulatory Infusion Pump, or CADD-Prizm PCSII Ambulatory Infusion Pump (software revision H or higher). The CADD-Solis Medication Safety Software- Point of Care allows use of a computer to send therapy-based protocols developed by the CADD-Solis Medication Safety Software.- Administrator to the CADD -Solis Ambulatory Inf...
Source: Medical Device Recalls - November 2, 2014 Category: Medical Equipment Source Type: alerts
Baxter Healthcare Corp. - SIGMA SPECTRUM Volumetric Infusion Pump - Class 1 Recall
SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product Usage: Sigma Spectrum Volumetric Infusion Pumps with Master Drug Library are intended to be used for the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 26, 2014 Category: Medical Equipment Source Type: alerts
Biomerieux France Chemin De L'Or - API Listeria (REF 10300)) - Class 2 Recall
API Listeria (REF 10300) API Listeria is a standardized system for the identification of Listeria which uses miniaturized tests, as well as a database. The ZYM B reagent is including in API Listeria kit and it is used as an additional reagent for revealing the result of DIM miniaturized biochemical test included in the API Listeria strips. ZYM B reagent is added in the DIM test before reading miniaturized biochemical test including in the API Listeria strips. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 28, 2014 Category: Medical Equipment Source Type: alerts
Biomerieux France Chemin De L'Or - API NH (REF 10400) - Class 2 Recall
API NH (REF 10400) API NH is a standardized system for the identification of Neisseria, Haemophilus (and related genera) and Moraxella catharrhalis (Branhamella catarrhalis), which uses miniaturized tests, as well as a specially adapted database. API NH also enables the biotyping of Haemophilus influenza and Haemophilus parainfluenxzae, as well as the detection of a penicllinase. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 28, 2014 Category: Medical Equipment Source Type: alerts
