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imaging
Company: Shanghai United Imaging Healthcare Co., Ltd. Date of Enforcement Report: 8/19/2020 Class II PRODUCT uEXPLORER PET/CT Diagnostic Imaging System – Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but...
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On July 16, 2020, FDA issued 510(k) Approval for AI Imaging Analytics Device HealthMammo, a device manufactured by Zebra Medical Vision Ltd. As reported in the New York Times, HealthMammo is an artificial intelligence (AI) product that analyzes mammograms for suspicious lesions. Radiologists can use the HealthMammo results to prioritize which mammogram images need attention...
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On February 25-26, 2020 the U.S. Food and Drug Administration (FDA) held a public workshop to discuss the “Evolving Role of Artificial Intelligence in Radiological Imaging.” The comment period for the public workshop is extended to June 30, 2020, in response to requests for an extension to allow stakeholders additional time to submit comments.
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In April 2019, FDA released a draft guidance providing manufacturers and FDA staff with detailed recommendations on assessing the technical performance of quantitative imaging devices and how the documentation from those assessments should be provided in premarket submissions. From a big picture perspective, one should remember the overall goal is to “provide performance specifications for...
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Company: GE Healthcare, LLC Date of Enforcement Report: 4/18/2019 Class II: PRODUCT Innova IGS 630, Angiographic X-Ray, s5i system option used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Recall Number: Z-1199-2019 Innova IGS 630, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational...
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Company: Synaptive Medical, Inc. Date of Enforcement Report: 10/9/2018 Class l: PRODUCT: Synaptive Medical’s BrightMatter Guide with SurfaceTrace Registration provides detailed three-dimensional (3D) images of a patient’s brain to help surgeons safely navigate surgical tools used during brain surgery. Recall Number: Z-0470-2019 REASON: Synaptive Medical has initiated this recall due to a software defect found in the BrightMatter...
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Company: Vision RT Ltd Date of Enforcement Report 10/10/2018 Class II: PRODUCT Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only Recall Number: Z-0065-2019 REASON RTInterface error in the event of an I/O error between the IGC PCB and the Framegrabber PCB RECALLING FIRM/MANUFACTURER Vision RT Ltd London, United Kingdom on 8/24/2018 Voluntary: Firm Initiated...
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Company: LIEBEL-FLARSHEIM COMPANY LLC Date of Enforcement Report 8/29/2018 Class II: PRODUCT Liebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, primarily for urological applications such as functional x-ray diagnostics, endourology and minimal invasive urology/ surgery.uch as functional x-ray diagnostics, endourology and minimal...
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Company:LIEBEL-FLARSHEIM COMPANY LLCDate of Enforcement Report 8/29/2018 Class lI: PRODUCT Liebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, primarily for urological applications such as functional x-ray diagnostics, endourology and minimal invasive urology/ surgery.uch as functional x-ray diagnostics, endourology and minimal invasive urology/...
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Company:Medtronic Navigation, Inc.Date of Enforcement Report 3/14/2018 Class lI: PRODUCT O-arm 1000 mobile image-intensified fluoroscopic x-ray system; (1) Model: BASE OARM Bl70000028100 SYS 100V, Product Number: Bl70000028100 (UDI: 00643169354418); (2) Model: BASE OARM Bl70000028120 SYS 120V, Product Number: Bl70000028120 (UDI: 00643169353411); (3) Model: BASE OARM Bl70000028120R SYS 120V RWK, Product Number: Bl70000028120R (UDI: 00643169353459); (4)...
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Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report 1/31/2018 Class lI: PRODUCT Syngo Imaging version V31 (model # 10014063) is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images. It supports the physician in diagnosis and treatment planning. Recall...
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Company:Volcano Corp.Date of Enforcement Report 12/6/2017 Class lI: PRODUCT Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF 400-0100.01; CORE Mobile Imaging System Refurbished REF 400-0100.01-R; CORE Mobile Imaging System (240V) REF 400-0100.07; CORE Mobile Imaging System Refurbished REF 400-0100.07-R; CORE Mobile Imaging System (100V) REF 400-0100.08; CORE Mobile Imaging System Refurbished...
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Company:Edap Technomed Inc. Date of Enforcement Report 11/1/2017 Class lI: PRODUCT Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue Recall Number Z-0049-2018 REASON The US FDA has requested the optional energy treatment settings, “medium” and “low” (Software Protocols 02-Medium and 03-Low) be...
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Company: Merge Healthcare, Inc. Date of Enforcement Report 8/17/2016 Class lI: PRODUCT Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images. Recall Number Z-2363-2016 REASON When measuring a lesion on an...
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Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 5/11/2016 Class lI: PRODUCT ACUSON SC2000 Ultrasound imaging system with software version VB10C and using transesophageal (TEE) transducer Z6Ms, V5Ms or V7M. Model number: 10433816. Recall Number Z-1592-2016 REASON While imaging with a transesophageal (TEE) transducer (Z6Ms, V5Ms, or V7M), user may lose the ability to...
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Company: Mckesson Medical Immaging Date of Enforcement Report 3/23/2016 Class lI: PRODUCT McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and McKesson Radiology (MR) products 12.0 and 12.1.1. Recall Number Z-1182-2016 REASON McKesson has identified a design deficiency where under rare circumstances, imported images/studies may re-use a non-unique image directory. This issue...
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Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 12/30/2015 Class lI: PRODUCT Syngo Imaging XS is a Picture Archiving and Communication System (PACS) Recall Number Z-0550-2016 REASON For the Syngo Workflow SLR System with Software Ver: VB10C: Printouts may be printed in incorrect anatomical size when using syngo Imaging XS filming application in conjunction...
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Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 12/2/2015 Class lI: PRODUCT Syngo Imaging VB36D_HF02. Radiological image processing system. Recall Number Z-0319-2016 REASON To provide supplementary information regarding the release of the syngo Imaging Software Version VB36D_HF02. The software provides improvements for all syngo Imaging installations running on the software Version VB36D. RECALLING FIRM/MANUFACTURER...
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Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 7/8/2015 Class lI: PRODUCT SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images. Recall Number Z-1972-2015 REASON Siemens became aware that during...
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Company: Mckesson Medical Immaging.Date of Enforcement Report:8/5/2014 Class lI: PRODUCT Horizon Medical Imaging It is a medical image and information management application that is intended to receive, transmit, store, retrieve, display print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems. Recall Number Z-2121-2014 REASON The firm...
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Company Siemens Medical Solutions USA, Inc Date of Enforcement Report 7/302014 Class lI: PRODUCT Siemens syngo Imaging XS, version VA70A or higher Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment...
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Company: Mckesson Medical Immaging.Date of Enforcement Report:6/18/2014 Class lI: PRODUCT Horizon Medical Imaging Horizon Medical Imaging is a medical image and information management application that is intended to receive transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems. Recall Number Z-1728-2014 REASON...
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Company Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/28/2014 Class lI: PRODUCT syngo Imaging XS Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo Imaging XS also...
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Company: Boston Scientific Corporation Date of Enforcement Report 4/30/2014 Class lI: PRODUCT iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular pathology. Recall Number Z-1487-2014 REASON Specific iLab Ultrasound Imaging Systems using newest 3.0 (Polaris 1.0) software change the pullback speed from the default setting of 0.5 mm/sec to...
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Company:Mckesson Information Solutions LLCDate of Enforcement Report:2/19/2014 Class lI: PRODUCT Horizon Medical Imaging, Picture Archive Communication System (PACS). Recall Number Z-0976-2014 REASON Images may be archived to an incorrect or invalid archive location resulting in incorrect images or no images being displayed for a study following retrieval from archive.. RECALLING FIRM/MANUFACTURER Mckesson Information Solutions LLC,...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report:2/122014 Class lI: PRODUCT Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMINI TF PET/CT16 Model #882470, GEMINI TF PET/CT 64 Model #882471, GEMINI TF Ready Model #882473 & GEMINI TF Big Bore Model #882476) Recall Number Z-0932-2014 REASON The PET Reconstruction Server (PRS)...
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Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report: 11/6/2013 Class lI: PRODUCT ngenuity TF PET/CT 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...
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Company: GE Healthcare It Date of Enforcement Report: 10/30/2013 Class lI: PRODUCT Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). Product Usage: It will be sold as a software only device to operate on general purpose computing hardware. Centricity Cardio Imaging receives medical images and other information from various...
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Company: Mckesson Information Solutions LLC Date of Enforcement Report: 10/9/2013 Class ll: PRODUCT McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6., is a medical image and information management application intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information...
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Company: GE Healthcare.Date of Enforcement Report: 5/8/2013 Class ll: PRODUCT GE Healthcare, Discovery MR750, Discovery 450, Optima 450W (with and without GEM), Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant. Indicated for use as a diagnostic imaging device. Recall Number Z-1207-2013 REASON GE Healthcare has recently become aware of a Reformat Image Flip Issue associated...
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Company:Philips Medical Systems .Date of Enforcement Report 4/10/2013 Class ll: PRODUCT Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. Recall Number Z-1029-2013 REASON Issues have been detected in the Ingenuity TF PET/CT currently running software version 4.0.60605.0 that if they were to re-occur, could cause...
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Company:GE Healthcare, LLC Date of Enforcement Report 3/20/2013 Class ll: PRODUCT Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, and GE 1.5T Signa HDe MR System. The GE Signa HDx MR system is a whole body magnetic resonance scanner. Z-0935-2013 REASON An error on the SR Viewer Reporting Tool...
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Company:Imaging Sciences International, LLC Date of Enforcement Report 9/26/12 Class ll: PRODUCT DEXIS Imaging Suite – catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 Radiological Image Processing System Recall Number Z-2463-2012 REASON A condition can occur during renumbering of the patient database using the DEXCopy feature. When renumbering is being performed using the DEXCopy feature...
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Company:GE Healthcare, LLC. Date of Enforcement Report 9/19/12 Class ll: PRODUCT 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....
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FDA released a new guidance dated July 3, 2012 entitled ” Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data – Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions. This guidance discusses types of Computer Aided Detection devices (CADe) and appropriate clinical data to include in 510(k)s and...
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Company:GE Healthcare, LLC Date of Enforcement Report 4/18/12 Class ll: PRODUCT GE Healthcare Innova X-ray Imaging Systems. The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures. This device is not intended...
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Company:Siemens Medical Solutions USA, Inc. Date of Enforcement Report 3/14/12 Class ll: PRODUCT Siemens syngo Imaging XS. Radiological image processing system. Model number 10496279. Recall # Z-1064-2012 REASON Firm became aware of an unintended behavior when using syngo Imaging XS, version VA70A and VA70B with Client/Server Installations. Loading additional images/series from the Patient Browser using...
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Company:Siemens Medical Solutions USA, IncDate of Enforcement Report 2/1/12 Class ll: PRODUCT Syngo Imaging XS, all versions Radiological image processing system. Model number 10496279. Recall # Z-0514-2012 REASON The “Rename” functionality can cause an unintended patient merge if the renamed patient is sent to another system. RECALLING FIRM/MANUFACTURER Recalling Firm: Siemens Medical Solutions USA, Inc.,...
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Company:Philips Medical Systems (Cleveland) Inc. Date of Enforcement Report 12/27/11 Class ll: PRODUCT 1) Philips GEMINI TF 16 Diagnostic CT X-ray/PET Imaging System, 510(k) #K052640. System units equipped with software version: 3.5.2 are subject to recall/field correction. The GEMINI TF I6, and TF 64 are diagnostic imaging systems for fixed or mobile installations that combine...
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Company: Philips Medical Systems Date of Enforcement Report 10/19/11 Class ll: PRODUCT 1) Philips GEMINI TF16 Diagnostic Imaging Systems, Model Number: 882470, 510(k) #K052640. The recalled GEMINI TF16 system units equipped with software versions: 3.5.1.1 and 3.5.2.1 are subject to recall/software correction. The GEMINI TFI6, TF64 and TF Big Bore (BB) are all diagnostic imaging...
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Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 4/6/2011 Class ll: PRODUCT Acuson Antares Ultrasound Imaging System with software versions 4.0 and 5.0. Model numbers: 10032747, 10037592, 10040728; SONOLINE Antares: Model numbers: 5936518, 08653771, 10037593; ACUSON Antares PE: Model Numbers: 10032746, 10037591, 10038202, 10040729. Recall # Z-1853-2011 REASON Image captured from the device may...
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Company:Volcano Corp., Date of Enforcement Report 12/8/2010 Class ll: PRODUCT Volcano s5/s5i imaging system Family Software version 3.2, Part Numbers 435-0602.01 to 05, including ChromaFlo and Virtual Histology. Recall # Z-0168-2011 REASON Software defect results in improper image brightness, which may result in introduction of artifacts, which may cause misclassification of results and affect classification...
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Company:Mckesson Medical ImagingDate of Enforcement Report 6/15//2010 Class:ll PRODUCT Voiceware clip software update to certain Horizon Medical Imaging Systems. Intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video and associated medical information from various medical imaging systems. Recall # Z-1735-2010 REASON Voice Clip issue: When the user is...
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Company: Gendex Dental SystemsDate of Enforcement Report 7/22/2009 Class:ll PRODUCT Gendex VixWin Platinum Imaging Software, Versions 1.0, 1.1 and 1.2; Intended for use of the software is to control capture, display, treatments, analysis and saving of x-ray digital images. Recall # Z-1548-2009 REASON There is a compatibility issue when the VixWin Platinum versions 1.0/1.1/1.2 software...
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Company:Siemens Medical Solutions USA, IncDate of Enforcement Report 5/6/2009 Class:ll PRODUCT syngo Imaging model number 10014063. Affected systems are V30A or earlier with an NFS connected archive and V30A systems where image data was stored to LTS using software version older than V30A. Picture Archiving and communications system. Recall # Z-1266-2009 REASON An issue concerning...
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Company:Medtronic Navigation, Inc Date of Enforcement Report 2/11/2009 Class:ll PRODUCT Medtronic O-Arm Intraoperative Imaging System, Catalog number: Bl-700-0027, Recall # Z-0624-2009 REASON Navigation accuracy problem: Accuracy may fall outside of specification when used in combination with the Medtronic Synergy Experience StealthStation System Spine Software with the O-Arm Intraoperative Imaging System and tracker. RECALLING FIRM/MANUFACTURER Recalling...
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Company: Konica Minolta Medical Imaging USA, Inc., Date of Enforcement Report:5/23/2006 Class:lI PRODUCT REGIUS Image Manager (AKA REGIUS IM, RIM). Catalogue Number 5900554. The Konica REGIUS Image Manager Software (RIM) is used to receive and manage computerized X-Ray image file workflow, Recall # Z-0862-06 REASON If the patient demographic data is entered into the CS-1...
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Company:Fischer Imaging Corporation, Date of Enforcement Report:4/19/2006 Class:lI PRODUCT SenoScan Full Field Digital Mammography System, Product number 94001G-3, 105200G, Recall # Z-0757-06 REASON Software upgrade to preclude lost images during mammography procedure. CODE Software versions earlier than 5.2.2 RECALLING FIRM/MANUFACTURER Fischer Imaging Corporation, Denver, CO, by letter on March 27, 2006, firm initiated recall is...
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What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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