Siemens Medical Solutions USA, Inc. - Class 2 Recall
The Symbia Intevo series consists of the Intevo 16, Intevo 6 and Intevo 2. This manual also describes the Symbia Intevo Excel. The Symbia Intevo series integrates state-of-the-art SPECT and high quality spiral CT to provide precise attenuation correction and anatomical mapping. The system can also be used as a complete clinical SPECT system for general purpose, whole body (WB) and SPECT applications. The Symbia Intevo Excel integrates state-of-the-art SPECT and high quality spiral CT to give the system SPECT functionality, with attenuation correction. The Symbia Intevo 2 integrates state-of-the-art SPECT and high quali...
Source: Medical Device Recalls - September 30, 2014 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc. - Class 2 Recall
The Symbia T Series consists of the T16, T6, T2, and T. The Symbia T integrates state-of-the-art SPECT and high quality spiral CT to provide precise attenuation correction and anatomical mapping. The system can also be used as a complete clinical SPECT system for general purpose, WB and SPECT applications. The Symbia T integrates state-of-the-art SPECT and high quality spiral CT to give the system SPECT functionality, with attenuation correction. The Symbia T2 integrates state-of-the-art SPECT and high quality dual slice spiral CT to give the system full functionality for all SPECT-only, SPECT-CT, or stand-alone CT dia...
Source: Medical Device Recalls - September 30, 2014 Category: Medical Equipment Source Type: alerts
Brainlab AG - Class 2 Recall
Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or Intraoperative 2D or 3D image data. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic...
Source: Medical Device Recalls - August 14, 2014 Category: Medical Equipment Source Type: alerts
Pentax Medical Company - Pentax Medical Inc. - Class 2 Recall
EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Product Usage: Intended to provide optical and sonographic visualization via a video monitor of and therapeutic access to the Upper Gastrointestinal Tract. The upper Gastrointestinal Tract include but is not restricted to the organs, tissues, and subsystems: Esophagus, Stomach and Duodenum. These are instruments are introduced per orally when indications consistent with the requirement for the procedure are observed in Adult and Pediatric patient population. Intend...
Source: Medical Device Recalls - July 25, 2014 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - Proteus XR/a - Class 2 Recall
GE Healthcare, Proteus XR/a. Proteus XR/a Intended Use: Is intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 3, 2014 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - Revolution XR/d. - Class 2 Recall
GE Healthcare, Revolution XR/d. Revolution XR/d Intended Use: The Revolution XR/d Digital Radiographic imaging system is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 3, 2014 Category: Medical Equipment Source Type: alerts
Blue Belt Technologies MN - Stride Femoral Component - Class 2 Recall
Stride Femoral Component Size 2, PFSI-00053, Right Lateral /Left Medial. Product Usage: The STRIDE Unicondylar Knee devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. These devices are indicated for cemented use only. The STRIDE Unicondylar Knee device is a unicompartmental prosthetic implant that resurfaces one femoral condyle, and one side of the tibial plateau. The femoral com...
Source: Medical Device Recalls - June 28, 2014 Category: Medical Equipment Source Type: alerts
Blue Belt Technologies MN - Stride Femoral Component - Class 2 Recall
Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Product Usage: The STRIDE Unicondylar Knee devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. These devices are indicated for cemented use only. The STRIDE Unicondylar Knee device is a unicompartmental prosthetic implant that resurfaces one femoral condyle, and one side of the tibial plateau. The femoral compo...
Source: Medical Device Recalls - June 28, 2014 Category: Medical Equipment Source Type: alerts
Intuitive Surgical, Inc. - Assembly, Patient Side Cart - Class 2 Recall
Assembly, Patient Side Cart, for use with da Vinci Surgical system IS 4000. Product Usage: The patient side cart is positioned at operating room table and contains four arms that are positioned over the target patient anatomy. The endoscope attaches onto any arm and provides a high resolution, three-dimensional view of the patient Anatomy. The patient side assistance attaches/detaches the endoscope and instrument intra-operatively. Intuitive Surgical, Inc. Sunnyvale, CA 94086 (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 5, 2014 Category: Medical Equipment Source Type: alerts
NEWYORK-PRESBYTERIAN AMENITY (Sodium Monofluorophospate) Kit [Anatomy Supply Partners, LLc]
Updated Date: May 15, 2014 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))
Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) - May 15, 2014 Category: Drugs & Pharmacology Source Type: alerts
Boston Scientific Corporation - iLab Ultrasound Imaging System - Class 2 Recall
iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Product Usage: The iLab Ultrasound Imaging System is intended for ultrasound examinations of intravascular pathology. Intravascular ultrasound is indicated in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy. Automatic Pullback is indicated for the following use cases: The physician/operator wants to standardize the method in which intravascular ultrasound images are obtained and documented: procedure-to-procedure, operator-to-operator. The physician/operator wants to make linear distance determi...
Source: Medical Device Recalls - April 23, 2014 Category: Medical Equipment Source Type: alerts
Brainlab AG - Spine & Trauma 3D 2.0 - Class 2 Recall
Spine & Trauma 3D 2.0 is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or Intraoperative 2D or 3D image data. The device enables computer-assisted navigation of medical image data, which can either be acquired preoperatively or intraoperatively by an appropriate image acquisition system. The software offers screw implant size planning and navigation on rigid bone structures with precalibrated and additional individually-calibrated...
Source: Medical Device Recalls - April 18, 2014 Category: Medical Equipment Source Type: alerts
Synthes, Inc. - Synthes Small Notch Titanium Reconstrcutive Plate - Class 2 Recall
Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synthes Small Notch Titanium Reconstructive Plate set offers fixation for immediate stabilization to allow bone fusion. Commercially pure titanium implants are biocompatible. The wide selection of implants accommodates variable anatomy; precisely crafted instruments facilitate implant placement. Implant plate lateral slant of holes allows for angulation of screws. Elongated central holes provide flexibility in screw placement. Wide selection of length's accommodates individual case requirements. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 12, 2014 Category: Medical Equipment Source Type: alerts
GE Healthcare, LLC - Xray System - Class 2 Recall
GE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Innova 2121IQ, Innova 3131IQ; Cardiovascular X-ray imaging systems (X-ray generator installed with Rotor V3 version and Heater V4 version boards). The Digital Fluoroscopic Imaging System is indicated for use in generating fluoroscopic images of human anatomy for diagnostic and intervention angiography procedures. It is intended to replace fluoroscopic images obtained through the image intensifier technology. This device is not intended for mammography applications. The Innova 3100 system is indicated for use in generating fluoroscopic i...
Source: Medical Device Recalls - March 11, 2014 Category: Medical Equipment Source Type: alerts
Medtronic Navigation, Inc. - Medtronic Oarm Imaging System - Class 2 Recall
Medtronic O-arm Imaging System Mobile X-ray system. The 0-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-ann Imaging System is compatible with certain Image Guided Surgery Systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 1, 2014 Category: Medical Equipment Source Type: alerts
