Baxter Healthcare Corporation - Baxter SIGMA Spectrum - Class 1 Recall
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 30, 2022 Category: Medical Devices Source Type: alerts
Biomerieux Inc - Kit, Identification, Yeast - Class 2 Recall
API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identification of yeasts. It uses miniaturized tests as well as a specially adapted database. After manual inoculation of the strip, reading can be performed either automatically or manually and the identification is obtained using an identification software. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 26, 2022 Category: Medical Devices Source Type: alerts
Baxter Healthcare Corporation - Sigma Spectrum Infusion Pump with Master Drug Library V6, V8, Spectrum IQ with Dose IQ Safety Softwa - Class 2 Recall
Infusion Pump (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 26, 2021 Category: Medical Devices Source Type: alerts
Baxter Healthcare Corporation - SIGMA Spectrum Infusion Pump - Class 2 Recall
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 24, 2020 Category: Medical Devices Source Type: alerts
Baxter Healthcare Corporation - SIGMA Spectrum Infusion Pump - Class 2 Recall
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage: intended to be used for the controlled administration of fluids. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 24, 2020 Category: Medical Devices Source Type: alerts
Baxter Healthcare Corporation - Baxter SIGMA Spectrum Infusion Pump - Class 1 Recall
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 23, 2020 Category: Medical Devices Source Type: alerts
Baxter Healthcare Corporation - Baxter SIGMA Spectrum Infusion Pump - Class 1 Recall
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 23, 2020 Category: Medical Devices Source Type: alerts
Remel Inc. - SWIN 2017 database, Model YSW4000 - Class 2 Recall
SWIN 2017 database, Model YSW4000 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 9, 2020 Category: Medical Devices Source Type: alerts
Fenwal Inc - VOLUMAT MC AGILIA US - Class 1 Recall
VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product Usage: The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare facilities environment by healthcare trained professionals according to hospital protocols on adults, pediatrics and neonatal human patient to administer via a single channel or mounted on a multiple channels rack accessory: Intermittent or continuous delivery of parenteral fluids (solutions, colloids, parenteral nutrition) and medications (including but limited to diluted drugs, chemotherapy) through clinically accepted IV ro...
Source: Medical Device Recalls - August 13, 2019 Category: Medical Devices Source Type: alerts
Fenwal Inc - Vigilant Agilia, Vigilant Drug'Lib - Class 1 Recall
Vigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1 Product Usage: Vigilant Drug Lib is Dose Error Reduction Software that, when used in combination with Volumat MC Agilia infusion pumps, is intended to reduce drug administration errors at the bedside. Vigilant Drug Lib Agilia is a software application running on a computer and intended to configure and generate multiple device configurations, drug libraries, care areas and data sets that can then be uploaded to the Volumat MC Agilia infusion pumps. Intended patient population: The Vigilant Drug Lib software must only be used to create drug librarie...
Source: Medical Device Recalls - August 13, 2019 Category: Medical Devices Source Type: alerts
Philips North America, LLC - Philips Patient Information Center iX - Class 3 Recall
Philips Patient Information Center iX configured with a regional setting which uses a comma for a decimal separator: 866389 Patient Information Center iX B.01 (or later); 866390 Patient Information Center iX B.01 upgrade (or later) Product Usage: The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart 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 ...
Source: Medical Device Recalls - June 13, 2019 Category: Medical Devices Source Type: alerts
Baxter Healthcare Corporation - Baxter SIGMA Spectrum Infusion Pump - Class 2 Recall
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), product code 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 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 intravenous...
Source: Medical Device Recalls - May 3, 2019 Category: Medical Devices Source Type: alerts
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 6), infusion pump, 35700BAX and 35700ABB 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 market...
Source: Medical Device Recalls - June 8, 2018 Category: Medical Devices Source Type: alerts
