Shanghai United Imaging Healthcare Co., Ltd. - uCT 550 - Class 2 Recall
Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036 Intended use The uCT Computed Tomography X-ray System uCT 530/uCT 550 is a computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck and vascular). (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 20, 2020 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - Class 2 Recall
ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600 (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 4, 2020 Category: Medical Devices Source Type: alerts
WELCH ALLYN, INC/MORTARA - Class 2 Recall
Q-Tel. The Q-Tel RMS system is a computer-based cardiac and pulmonary rehabilitation data acquisition and editing system. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 30, 2020 Category: Medical Devices Source Type: alerts
Intellijoint Surgical, Inc. - Intellijoint Navigation System - Class 2 Recall
Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage: The Intellijoint Navigation System is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedic implant system components, where a reference to a rigid anatomical structure can be identified. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 24, 2020 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - Siemens SOMATOM go.Top - Class 2 Recall
SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 22, 2019 Category: Medical Devices Source Type: alerts
Neocis Inc. - Neocis Guidance System Fiducial Array - Class 2 Recall
Neocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intraoperative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments. Fiducial Arrays are plastic parts that contain metal beads, which serve as the fiducial CBCT markers. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 22, 2019 Category: Medical Devices Source Type: alerts
Galil Medical, Inc. - VisualICE Cryoablation System - Class 2 Recall
Visual-ICE Cryoablation System, FPRCH6000. The cryoablation system is a mobile console system intended for cryoablative tissue destruction using a minimally invasive procedure. The system is computer-controlled with a touch screen user interface that allows the user to control and monitor the procedure. The therapy delivered by the system is based on the Joule-Thomson effect displayed by compressed gases. The Visual-ICE System uses high-pressure argon gas that circulates through closed-tip cryoablation needles to induce tissue freezing. Active tissue thawing is achieved by circulating helium gas through the needles or, alt...
Source: Medical Device Recalls - November 15, 2019 Category: Medical Devices Source Type: alerts
LivaNova USA Inc - VNS Therapy, Sentiva, - Class 2 Recall
The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. The generator is an implantable, multi-programmable pulse generator that delivers electrical signals to the vagus nerve through the lead. The generator is housed in a hermetically sealed titanium case and is powered by a single battery. Electrical signals are transmitted from the generator to the vagus nerve by the lead. The lead and the generator make up the implantable portion of the VNS Therapy System. The VNS Therapy Progra...
Source: Medical Device Recalls - November 8, 2019 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - SOMATOM go.All - Class 2 Recall
SOMATOM go.All; Models #11061638 Product Usage: This computed tomography system is 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 - August 29, 2019 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - SOMATOM go.Top - Class 2 Recall
SOMATOM go.Top; Models #11061640 Product Usage: This computed tomography system is 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 - August 29, 2019 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - SOMATOM go.Now - Class 2 Recall
SOMATOM go.Now; Models #11061610 & 11061618 Product Usage: This computed tomography system is 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 - August 29, 2019 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - SOMATOM go.All - Class 2 Recall
SOMATOM go.All; Models #11061630 Product Usage: This computed tomography system is 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 - August 29, 2019 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - SOMATOM go.Up - Class 2 Recall
SOMATOM go.Up; Models ##11061628 Product Usage: This computed tomography system is 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 - August 29, 2019 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - SOMATOM go.Top - Class 2 Recall
SOMATOM go.Top; Models #11061648 Product Usage: This computed tomography system is 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 - August 29, 2019 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - SOMATOM go.Up - Class 2 Recall
SOMATOM go.Up; Models #11061620 Product Usage: This computed tomography system is 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 - August 29, 2019 Category: Medical Devices Source Type: alerts
