Medicine RSS Search Engine

X-Ray alerts X-Ray alerts RSS feedThis is an RSS file. You can use it to subscribe to this data in your favourite RSS reader, such as GoogleReader, or to display this data on your own website or blog.subscribe with FeedlySubscribe to this data using Feedly.

This page shows you the latest alerts in this category.

GE Healthcare, LLC - GE Healthcare Optima CT580/Discovery CT590RT scanners - Class 2 Recall
GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3. The Discovery CT 590 RT and Optima CT 580 series of Computed Tomography systems are intended to produce cross-sectional images of the body by computer reconstruction of XRay transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), and Gated (Respiratory and Cardiac) acquisitions in patients of all ages. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 21, 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 ima...
Source: Medical Device Recalls - March 11, 2014 Category: Medical Equipment Source Type: alerts

Shimadzu Medical Systems - MUX100, MUX100H Xray System - Class 2 Recall
Mobile X-ray System, Model: MUX-100, MUX-100H Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannnot move and/or of outpatients in emergency (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 8, 2014 Category: Medical Equipment Source Type: alerts

Carestream Health Inc. - Model Kodak 2200 Intraoral XRay System - Class 2 Recall
Model Kodak 2200 Intraoral X-Ray System, Catalog Numbers 5303177, 5303169, 5303151, XR-5154323 -- Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608 -- Made in France -- TROPHY 77435 Marne La Vallee --- COMMON/USUAL NAME: Dental X-Ray Systems -- CLASSIFICATION NAME: Unit, X-Ray, Extraoral with timer --- There are four major components: x-ray tube, x-ray generator, collimator and image receptor. These systems are permanently installed diagnostic dental x-ray systems for generation of x-rays for examination of the teeth, jaw and oral structures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 5, 2014 Category: Medical Equipment Source Type: alerts

Carestream Health Inc. - Model Kodak 2100 Intraoral XRay System - Class 2 Recall
Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 -- Made in France -- TROPHY 77435 Marne La Vallee --- COMMON/USUAL NAME: Dental X-Ray Systems -- CLASSIFICATION NAME: Unit, X-Ray, Extraoral with timer --- There are four major components: x-ray tube, x-ray generator, collimator and image receptor. These systems are permanently installed diagnostic dental x-ray systems for generation of x-rays for examination of the teeth, jaw and oral structures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 5, 2014 Category: Medical Equipment Source Type: alerts

Toshiba American Medical Systems Inc - TSXIOIA: Aquilion 32/64 ONE; System, XRay, Tomography, Computed - Class 2 Recall
" TSX-IOIA: Aquilion 32/64 ONE; System, X-Ray, Tomography, Computed " TSX-101/R: Aquilion RXL; System, X-Ray, Tomography, Computed " TSX-301A: Aquilion One; System X-Ray, Tomography, Computed " TSX-301B: Aquilion Premium; System X-Ray, Tomography, Computed " TSX-302A Aquilion Prime; System X-Ray, Tomography, Computed This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head. The Aquilion RXL has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and...
Source: Medical Device Recalls - March 4, 2014 Category: Medical Equipment Source Type: alerts

Elekta, Inc. - Synergy xray volume imaging (XVI); Elekta Synergy; Elekta Synergy S and XVI - Class 2 Recall
Synergy XVI The Elekta Synergy S is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 21, 2014 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - Precision 500D R&38;F Xray System - Class 2 Recall
GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems. The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. The Precision 500D R&F X-ray Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the ...
Source: Medical Device Recalls - February 4, 2014 Category: Medical Equipment Source Type: alerts

Carestream Health Inc. - Carestream DRX Evolution System (Standard Q) - Class 2 Recall
Carestream DRX Evolution System (Standard Q) The DRX-Evolution System (Standard Q) is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstandbucky to complete x-ray exposures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 30, 2014 Category: Medical Equipment Source Type: alerts

Carestream Health, Inc. - Carestream DRXEvolution with Full Featured (FF) Wall Stand (WS) - Class 2 Recall
DRX-Evolution with FF WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky to complete x-ray exposures. The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 22, 2014 Category: Medical Equipment Source Type: alerts

Carestream Health, Inc. - Kodak DirectView DR 7500 System with motorized Wall Stand (WS) - Class 2 Recall
DR 7500 with FF WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky to complete x-ray exposures. The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 22, 2014 Category: Medical Equipment Source Type: alerts

Carestream Health, Inc. - Carestream DRXEvolution with Carestream Health (CSH) Wall Stand (WS) - Class 2 Recall
DRX-Evolution with CSH WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky to complete x-ray exposures. The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 22, 2014 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - Optima Mobile Xray System - Class 2 Recall
GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems. Model numbers 5555000-5, 5555000-6, and 5421698. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 12, 2014 Category: Medical Equipment Source Type: alerts

Midmark Corp dba Progeny Inc - Vantage Panoramic XRay System - Class 2 Recall
The Vantage Digital Panoramic System delivers high-value features standard on every system: - Five pre-programmed exam settings, including bitewing, minimize exam set-up time and allow routine diagnostic exams to be performed extraorally for improved clinical efficiency and patient experience. - Progeny Clarity Enhanced Filter Set provides superior diagnostic imaging quality - Exclusive Focal Trough Alignment reminder assists in consistent patient positioning - Progeny Imaging software included for download on an unlimited number of operatory workstations with no additional costs - Exclusive VantageTrust remote support and...
Source: Medical Device Recalls - January 10, 2014 Category: Medical Equipment Source Type: alerts

Carestream Health Inc. - DRXRevolution Mobile XRay System - Class 2 Recall
Carestream DRX-Revolution Mobile X-Ray System -- Made in U.S.A. by Carestream Health Inc. 150 Verona Street, Rochester, NY . 14608 --- The DRX Revolution Mobile system is a mobile diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. These products are mobile diagnostic x-ray systems designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 4, 2014 Category: Medical Equipment Source Type: alerts

Philips Medical Systems (Cleveland) Inc - Brilliance iCT Computed Tomography XRay System, - Class 2 Recall
Brilliance iCT Computed Tomography X-Ray System, Product Usage: The Brilliance iCT 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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 16, 2013 Category: Medical Equipment Source Type: alerts

Carestream Health Inc. - DRX Revolution Mobile Xray System - Class 2 Recall
DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 to perform radiographic x-ray examinations on all pediatric and adult patients (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 8, 2013 Category: Medical Equipment Source Type: alerts

Carestream Health Inc. - DRX Revolution Mobile Xray System - Class 2 Recall
DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/ parts warranty, US-only). The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 2, 2013 Category: Medical Equipment Source Type: alerts

Carestream Health, Inc. - DRX Revolution Mobile XRay System - Class 2 Recall
DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY 14608 Catalog Numbers 1019397, 1023415, 1023423 --- Made in USA by Carestream Health, Inc. 150 The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 1, 2013 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - GE Healthcare Discovery IGS 730 Cardiovascular XRay Imaging System - Class 2 Recall
GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System. The angiography X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image guided surgical procedures. The OR table is suitable for interventional and surgical procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 19, 2013 Category: Medical Equipment Source Type: alerts

Carestream Health Inc. - Carestream DRX Evolution System - Class 2 Recall
Carestream DRX Evolution System, X-ray system The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 13, 2013 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - GE LightSpeed CT750 HD Computed Tomography Xray System - Class 2 Recall
GE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, Spectral, and Gated acquisitions for all ages. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 10, 2013 Category: Medical Equipment Source Type: alerts

Toshiba American Medical Systems Inc - TOSHIBA Kalare XRay System - Class 2 Recall
TOSHIBA Kalare Diagnostic X-Ray System K110785 (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 11, 2013 Category: Medical Equipment Source Type: alerts

CEFLA DENTAL GROUP - MY Ray RXDC xray unit - Class 2 Recall
MyRay RXDC dental unit x-ray unit (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 24, 2013 Category: Medical Equipment Source Type: alerts

Philips Healthcare Inc. - Philips Healthcare Computed Tomography XRay System - Class 2 Recall
Philips Healthcare Computed Tomography X-Ray System. These devices are whole-body computed tomography (CT) x-ray systems or sub-systems, each with a continuously rotating x-ray tube and multi-row detectors enclosed by a gantry. X-ray transmission data acquired and taken at different angles can be reconstructed into cross-sectional images. Each device also includes signal analysis and display equipment, patient and equipment supports, components, and accessories. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 18, 2013 Category: Medical Equipment Source Type: alerts

DeGotzen - Generator, HighVoltage , X Ray Diagnostic - Class 2 Recall
DeGotzen XRay unit XGenus Dental X-ray unit. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 18, 2013 Category: Medical Equipment Source Type: alerts

Toshiba American Medical Systems Inc - TSX30IC: AQUlLlON ONE; System, XRay, Tomography, Computed. - Class 2 Recall
ToshibaTSX-30IC AQUlLlON ONE System, X-Ray, Tomography, Computed. This system supports Whole body scanning. 510(k) Number: KI22109 Device Listing Number: Dl56065 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 9, 2013 Category: Medical Equipment Source Type: alerts

Toshiba American Medical Systems Inc - Toshiba Infinixi XRay System - Class 2 Recall
Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 26, 2013 Category: Medical Equipment Source Type: alerts

Philips Medical Systems (Cleveland) Inc - Brilliance 64 and Ingenuity Computed Tomography XRay Systems - Class 2 Recall
Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 15, 2013 Category: Medical Equipment Source Type: alerts

Philips Medical Systems (Cleveland) Inc - Brilliance Big Bore and Brilliance Big Bore Oncology CT XRay Scanners - Class 2 Recall
Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore, Model #728243; and Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore Oncology, Model #728244, 510(k) #K033357. The Brilliance CT Big Bore is a Computed Tomography X-Ray System which produces cross-sectional body images by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include display equipment, signal analysis, as well as patient and equipment supports, components and accessories. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 27, 2013 Category: Medical Equipment Source Type: alerts

Philips Medical Systems (Cleveland) Inc - Brilliance Big Bore and Brilliance Big Bore Oncology CT XRay Scanners - Class 2 Recall
Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260, 510(k) #K012009. The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional body images by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, as well as patient and equipment supports, components and accessories. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 27, 2013 Category: Medical Equipment Source Type: alerts

Philips Medical Systems (Cleveland) Inc - GEMINI LXL, TF 16 and TF64, PET & XRay CT scanning systems - Class 2 Recall
GEMINI LXL - Model #882412; GEMINI TF 16 - Model #882470 and Model #882473; GEMINI TF 64 - Model #882471, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning systems, 510(k) #K052640. The GEMINI TFI 6, TF 64 are diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 27, 2013 Category: Medical Equipment Source Type: alerts

Philips Medical Systems (Cleveland) Inc - GEMINI Big Bore PET & XRay CT scanning systems - Class 2 Recall
GEMINI TF Big Bore, Model #882476, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning system, 510(k) #K081135. The GEMINI Big Bore is a diagnostic imaging systems for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 27, 2013 Category: Medical Equipment Source Type: alerts

Philips Medical Systems (Cleveland) Inc - Mx8000 IDT Whole Body Computed Tomography Xray system - Class 2 Recall
Mx8000 IDT Whole Body Computed Tomography X-ray system Distributed by Philips Medical Systems, Highland Heights, OH 44143 The Brilliance Scanner are computed Tomography X-ray systems with multi-slice capability of up to 16 slices,which are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 27, 2013 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - GE Healthcare Brivo XR385 DRF/ XRay System - Class 2 Recall
GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 27, 2013 Category: Medical Equipment Source Type: alerts

Philips Medical Systems (Cleveland) Inc - Computed Tomography XRay System Brilliance Workspace Portal - Class 2 Recall
Computed Tomography X-Ray System Brilliance Workspace Portal, Model #728269 Philips Medical Systems, Highland Heights, OH. The Brilliance Workspace Portal is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. The portal (together with the scanner) provides image processing and display through software applications that process, analyze, display, quantify and interpret medical images/data. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 17, 2013 Category: Medical Equipment Source Type: alerts

Philips Medical Systems (Cleveland) Inc - Computed Tomography XRay System, Extended Brilliance Workspace ( EBW) - Class 2 Recall
Computed Tomography X-Ray System, Extended Brilliance Workspace (EBW), Model #728260 Philips Healthcare, Highland Heights, OH The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 22, 2012 Category: Medical Equipment Source Type: alerts

Shimadzu Medical Systems - R20J, Diagnostic Xray Beam Limiting Device - Class 2 Recall
R-20J , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-Ray tubes: 06/1.2P364DK-85, 0.6/1.2P324DK-125, 06/1.2P324DK-85, 0.6/1.2P38DE-85. Product Usage: The device is the beam-limiting device for X-ray Radiography. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 9, 2012 Category: Medical Equipment Source Type: alerts

Shimadzu Medical Systems - System, xray, mobile - Class 2 Recall
0.7/1.2JG326D-265 Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 9, 2012 Category: Medical Equipment Source Type: alerts

Shimadzu Medical Systems - MUX100H. Mobile xray system. - Class 2 Recall
0.7U163CS-36 In combination with below systems MUX-100H, MUX-100D, MobileArt Evolution Brand Name: MUX-100H. Classification Name: Mobile x-ray system. Device Model#MUX-100H. Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 9, 2012 Category: Medical Equipment Source Type: alerts

Shimadzu Medical Systems - System, xray, mobile - Class 2 Recall
0.4/0.7JG326D-265AX/AT Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 9, 2012 Category: Medical Equipment Source Type: alerts

Shimadzu Medical Systems - R30H, Diagnostic Xray Beam Limiting Device - Class 2 Recall
R-30H , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-ray tubes 0.6/1.2P364DK-85, 0.6/1.2P324DK-125, 0.6/1.2P324DK-85, 0.6/1.2P38DE-85 Device Model # R-30H. Subsequent Product Code: IZX Product Usage: The device is the beam-limiting device for X-ray Radiography. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 9, 2012 Category: Medical Equipment Source Type: alerts

Philips Healthcare Inc. - System, Xray Stationary - Class 2 Recall
Philips Digital Diagnost-Mobile Detector Holder for Digital Diagnost (Single Detector, Dual Detector, Release 3) System codes: 712020, 712022, 712025 This system is used for making X-ray exposures for diagnostics. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 28, 2012 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular Xray imaging systems. - Class 2 Recall
GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems. K060259: The Innova 3131IQ (3131-IQ) and 2121 IQ (2121-IQ) biplane systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography app...
Source: Medical Device Recalls - September 14, 2012 Category: Medical Equipment Source Type: alerts

Toshiba American Medical Systems Inc - Scanner, Computed Tomography, XRay - Class 2 Recall
Toshiba CT systems, Asteion and Aquilion, that are equipped with a PC based computer, or to those older systems (SGI based) that received an improved table by an upgrade purchase. This device is designed to produce cross-sectional images of a human body by reconstruction of xray transmission data from the same axial plane taken at different angles. These images have been proven to be clinically useful in the diagnosis of spine and head injuries, intracranial tumors, blood clots in the brain, eye trauma, soft tissue lesions in the extremities, gastrointestinal lesions, abdominal and pelvic malignancies, and hepatic metast...
Source: Medical Device Recalls - August 25, 2012 Category: Medical Equipment Source Type: alerts

GE OEC Medical Systems, Inc - GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes - Class 2 Recall
GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 23, 2012 Category: Medical Equipment Source Type: alerts

Philips Medical Systems (Cleveland) Inc - Positron Emission Tomography (PET) and Xray Computed Tomography - Class 2 Recall
Positron Emission Tomography (PET) and X-ray Computed Tomography, GEMINI TF 16 PET/CT, GEMINI GXL 16 PET/CT, GEMINI TF Big Bore PET/CT, Philips Medical Systems, Cleveland, OH. The device is a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, he...
Source: Medical Device Recalls - August 23, 2012 Category: Medical Equipment Source Type: alerts

GE OEC Medical Systems, Inc - Fluoroscopic XRay System - Class 2 Recall
GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT. Mobile fluoroscopic examination of human anatomy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2012 Category: Medical Equipment Source Type: alerts

Philips Healthcare Inc. - Philips Essenta DR, XRay System - Class 2 Recall
Philips Essenta DR, X-Ray System, Diagnostic, general-purpose Model: 712070. The Essenta DR is a multifunctional stationary X-ray Intended Use From Labeling): system, in which the swivel arm rotation, the vertical movement of the swivel arm and the SID adjustment are motorized. It is designed for radiographic examination of the recumbent, standing or seated patient and also for lateral exposures. It enables the operator to quickly and safely move the unit to all the pre-programmed basic positions at the press of a button, using the autopositioning feature. Fine positioning of the tube/collimator and detector on the patien...
Source: Medical Device Recalls - August 16, 2012 Category: Medical Equipment Source Type: alerts

Philips Healthcare Inc. - Philips Easy Diagnost ClassicStationary xray system - Class 2 Recall
Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642, 70643, 706030, 706031, 706032 Stationary x-ray system, Universal RF system for general use. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 16, 2012 Category: Medical Equipment Source Type: alerts