MicroAire Surgical Instruments, LLC - MicroAire SmartRelease Endoscopic System - Class 2 Recall
MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece, containing IFU rev. D The MicroAire Carpal Tunnel Release System is for use in patients diagnosed with carpal tunnel syndrome that is not associated with, or secondary to, any other known pathology (i.e., idiopathic carpal tunnel syndrome). Preoperative x-rays of the wrist, including a carpal tunnel view, are recommended to aid in the diagnosis of associated pathology (i.e., calcific tendonitis, fracture of the hook of the hamate). This device is indicated for releasing the transverse carpal ligament (flexor retinaculum). (...
Source: Medical Device Recalls - May 26, 2018 Category: Medical Devices Source Type: alerts
Visaris DOO - Vision (Vision C, Vision U, and Vision V) - Class 2 Recall
Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.4 The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and tertiary levels of medical care. Powerful positioning capability makes this system particularly suited for institutions with immobile or hardly mobile patients, such as trauma wards and emergency departments. The system s versatility also makes it suitable for unified diagnostic imaging services for medium size hospitals where this system can cover all diagnostic radiography needs. In general, Vision systems are intended to posit...
Source: Medical Device Recalls - May 16, 2018 Category: Medical Devices Source Type: alerts
Visaris DOO - Vision (Vision C, Vision U, and Vision V) - Class 2 Recall
Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.3 The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and tertiary levels of medical care. Powerful positioning capability makes this system particularly suited for institutions with immobile or hardly mobile patients, such as trauma wards and emergency departments. The system s versatility also makes it suitable for unified diagnostic imaging services for medium size hospitals where this system can cover all diagnostic radiography needs. In general, Vision systems are intended to positi...
Source: Medical Device Recalls - May 16, 2018 Category: Medical Devices Source Type: alerts
Visaris DOO - Vision (Vision C, Vision U, and Vision V) - Class 2 Recall
Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.2 The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and tertiary levels of medical care. Powerful positioning capability makes this system particularly suited for institutions with immobile or hardly mobile patients, such as trauma wards and emergency departments. The system s versatility also makes it suitable for unified diagnostic imaging services for medium size hospitals where this system can cover all diagnostic radiography needs. In general, Vision systems are intended to posit...
Source: Medical Device Recalls - May 16, 2018 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc. - Biograph Horizon PET/CT - Class 2 Recall
Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 3, 2018 Category: Medical Devices Source Type: alerts
Bard Brachytherapy, Inc. - Bard BrachySource Seed Implants - Class 2 Recall
BARD¿ BrachySource¿ Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto a nickel / copper-coated, gold-cored aluminum wire (reference Figure 1 below). The I125 has a half-life of 59.6 days and decays by electron capture with the emission of characteristic photons and Auger electrons. The principal photon emissions are 27.4 and 31 keV x-rays and 35.5 keV gamma. The titanium wall of the BrachySource¿ Seed Implants absorbs the electrons. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 28, 2018 Category: Medical Devices Source Type: alerts
Toshiba American Medical Systems Inc - INFX8000C Fluoroscopic XRay Systems - Class 2 Recall
INFX-8000C Fluoroscopic X-Ray Systems (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 3, 2018 Category: Medical Devices Source Type: alerts
Toshiba American Medical Systems Inc - INFX8000H Fluoroscopic XRay Systems - Class 2 Recall
INFX-8000H Fluoroscopic X-Ray Systems (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 3, 2018 Category: Medical Devices Source Type: alerts
Toshiba American Medical Systems Inc - INFX8000V Fluoroscopic XRay Systems; INFINIX CFI/BP PLUS CARDIAC SYSTEM - Class 2 Recall
INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 3, 2018 Category: Medical Devices Source Type: alerts
Toshiba American Medical Systems Inc - INFX8000F Fluoroscopic XRay Systems - Class 2 Recall
INFX-8000F Fluoroscopic X-Ray Systems (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 3, 2018 Category: Medical Devices Source Type: alerts
NeuroLogica Corporation - GC80 Digital Xray Imaging System - Class 2 Recall
The GC80 Digital X-ray Imaging System (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 3, 2018 Category: Medical Devices Source Type: alerts
Philips Electronics North America Corporation - Allura Xper Philips Xray Systems - Class 2 Recall
Allura Xper systems with Certeray X-ray Generator located in regions with high mains (480V) voltage. Product Usage: The Allura Xper series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemake...
Source: Medical Device Recalls - February 25, 2018 Category: Medical Devices Source Type: alerts
Fujifilm Medical Systems U.S.A., Inc. - FullField Digital Mammography Xray System - Class 2 Recall
Fuji Computed Radiography Mammography Suite, FCRMS (for CR-IR363AWS) The Fuji Computed Radiography Mammography Suite (FCRMS) is a software device that, in conjunction with a specified Fuji Computed Radiography system forms the Fuji Computed Radiography for mammography (FCRm) device. FCRm with a dedicated mammographic x-ray machine generates digital mammographic images that can be used for screening and diagnosis of breast cancer. It is intended for use in the same clinical applications as traditional screen-film based mammographic (SFM) systems. The mammographic images can be interpreted by a qualified physician using ei...
Source: Medical Device Recalls - February 21, 2018 Category: Medical Devices Source Type: alerts
Fujifilm Medical Systems U.S.A., Inc. - FullField Digital Mammography Xray System - Class 2 Recall
ASPIRE Cristalle (for FDR-3000AWS) The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR MS-3500) generates full field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 21, 2018 Category: Medical Devices Source Type: alerts
Fujifilm Medical Systems U.S.A., Inc. - FullField Digital Mammography Xray System - Class 2 Recall
Aspire HD Plus, Aspire HD-s (for FDR-2000AWS) The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire ND-s (FDR MS-2000), generate full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 21, 2018 Category: Medical Devices Source Type: alerts
