Thoratec Corp. - HeartMate II Left Ventricular Assist System - Class 1 Recall
HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate IITM Sealed Outflow Graft with Bend Relief REF 103393 2. HeartMate IITM LVAS Implant Kit, US REF 106015 3. HeartMate IITM LVAS Implant Kit, OUS REF 106016 Update (February 14, 2024) HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II¿ LVAS Implant Kit, OUS REF 102139 2. HeartMate II¿ LVAS Implant Kit, US REF 1355 3. HeartMate II¿ LVAS Implant Kit (with RSOC Controller), US REF 103695 4. HeartMate II¿ LVAS Implant Kit (with RSOC Controller), OUS REF 103693 5. HeartMate II¿ LVAS Implant Kit (with Sealed Graft), US REF 1...
Source: Medical Device Recalls - March 23, 2024 Category: Medical Devices Source Type: alerts

Canon Medical System, USA, INC. - Alphenix, INFX8000C/B, INFX8000C/S, V9.2 - Class 2 Recall
The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm which is equipped with an X-ray tube, beam limiter and X-ray receptor, X-ray controller, computers with system and processing software, and a patient radiographic table. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 17, 2024 Category: Medical Devices Source Type: alerts

Canon Medical System, USA, INC. - Alphenix, INFX8000F/B, V8.0 - Class 2 Recall
The INFX-8000F is designed to take advantage of the latest technological innovations to reduce dose and to save time. A revolutionary graphic user interface and a multi-tasking computer enable the system to fully meet the requirement for optimum image quality, safety, ease of use, advanced efficiency and improved workflow. The advanced floormounted system INFX-8000F uses a new flat panel detector to present fluoroscopic and fluorographic images of high quality. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 17, 2024 Category: Medical Devices Source Type: alerts

Philips North America Llc - Philips Incisive CT - Class 2 Recall
The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment supports, components, and accessories. Philips Inclusive CT has a 72cm bore and includes a detector array that provides 50cm scan field of view. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 19, 2023 Category: Medical Devices Source Type: alerts

BioFire Diagnostics, LLC - BIOFIRE FilmArray TORCH - Class 2 Recall
FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes barcode scanner, touch screen computer and USB ports. The BioFire FilmArray Torch (BioFire Torch) is an automated in vitro diagnostic (IVD) device intended for use with FDA-cleared or approved IVD BioFire FilmArray Panels. Additional Part/Reference Numbers as part of the system: - HTFA-ASY-0102: BIOFIRE TORCH Duplex. This is a plastic component that covers the BIOFIRE TORCH Modules. The BIOFIRE TORCH Duplex is only necessary if the system includes more than two modules. - HFTA-SUB-0103: BIOFIRE TORCH Module. The BIOFIRE reagent pouc...
Source: Medical Device Recalls - November 21, 2023 Category: Medical Devices Source Type: alerts

COMPUTER EYE RELIEF (conium maculatum and natrium muriaticum and ruta graveolens and senega officinalis) solution/ drops [Similasan AG]
Updated Date: Fri, 06 Jan 2023 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - January 6, 2023 Category: Drugs & Pharmacology Source Type: alerts

COMPUTER EYE RELIEF (conium maculatum and natrium muriaticum and ruta graveolens and senega officinalis) solution/ drops [Similasan Corporation]
Updated Date: Fri, 06 Jan 2023 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - January 6, 2023 Category: Drugs & Pharmacology Source Type: alerts

Siemens Medical Solutions USA, Inc - Sensis - Class 2 Recall
Programmable Diagnostic Computer (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 2, 2023 Category: Medical Devices Source Type: alerts

Medacta Usa Inc - Medacta NextAR - Class 2 Recall
NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical navigation platform used to perform a reverse shoulder arthroplasty on the glenoid (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 4, 2022 Category: Medical Devices Source Type: alerts

GE Healthcare, LLC - GE Centricity - Class 2 Recall
GE Centricity Universal Viewer Zero Footprint. To view, communicate, process, and display Medical images and data within a computer network or on a workstation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 6, 2022 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - Sensis recording system - Class 2 Recall
Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 10765502 10910620 (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 7, 2022 Category: Medical Devices Source Type: alerts

SIGHT DIAGNOSTICS LTD - Sight OLO - Class 2 Recall
The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image processing to identify and quantify blood components (e.g., red blood cells) and their characteristics (e.g., cell volume) in an automated fashion. Using dedicated staining, the proposed platform provides complete blood count analysis. The Sight OLO is a compact device, designed to be automated and simple to operate, to enable rapid testing and analysis. The Sight OLO consists of a scanning and analyzing device and a CBC test kit, including disposable cartridges and sample preparation tool...
Source: Medical Device Recalls - April 22, 2022 Category: Medical Devices Source Type: alerts

Diagnos Inc - Class 2 Recall
CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 26, 2022 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - Programmable Diagnostic Computer - Class 2 Recall
1. Sensis, material # 10764561; UDI : 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo, material # 11007642; UDI: 04056869010205 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 15, 2022 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - Class 2 Recall
Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP5, VA30A_SP2, VA30A_SP2a, VA30A_SP3,VA30A_FP2 in Somatom systems: SOMATOM go.Up - Model 11061620 SOMATOM go.Up - Model 11061628 SOMATOM go.All - Model 11061630 SOMATOM go.Top - Model 11061640 SOMATOM X.cite - Model 11330001 Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 22, 2021 Category: Medical Devices Source Type: alerts