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imaging
Company: Philips Respironics, Inc. Date of Enforcement Report: 8/25/2021 Class II PRODUCT Trilogy Evo, Product numbers: BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, EE2110X15B, ES2110X15B, EU2110X15B, EU2110X19, FR2110X14B, GB2110X15B, IA2110X15B, IN2110X15B, IN2110X19, IT2110X21B, KR2110X15B, LA2110X15B, LD2110X23B, ND2110X15B, RDE2110X13B, UDS2110X11B Recall Number: Z-2287-2021 REASON Two software issues have been identified related to pressure increase in the device: The first...
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Company: Abbott Laboratories, Inc Date of Enforcement Report: 8/18/2021 Class II PRODUCT Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis screening, and organ donor centers, hospitals, and reference laboratories. Recall Number: Z-2241-2021 REASON A design defect (hardware and software) allows liquid waste...
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Company: Beckman Coulter, Inc. Date of Enforcement Report: 8/18/2021 Class I PRODUCT Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10574 – Kaluza C Single Perpetual License C10575 – Kaluza C Single User 1-year License C10576 – Kaluza C 10 User Network License C10577 – Kaluza C 5 User Network License C10578...
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Company: Baxter Healthcare Corporation Date of Enforcement Report: 8/18/2021 Class I PRODUCT Dose IQ Safety Software used with Spectrum IQ Infusion Pump Recall Number: Z-2165-2021 REASON Software issue: The defect creates a mismatch between linked drug identifiers (IDs) in the Dose IQ user interface (UI) and the binary drug library (BDL) loaded onto the Spectrum...
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Company: Simpleware Product Group, SYNOPSYS NORTHERN EUROPE Date of Enforcement Report: 8/18/2021 Class II PRODUCT Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options. Recall Number: Z-2253-2021 REASON A issue (bug) has been identified with the interface and image software which could...
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Company: Baxter Healthcare Corporation Date of Enforcement Report: 8/18/2021 Class I PRODUCT Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids. Recall Number: Z-2110-2021 REASON System errors were noted following changes the customers implemented to the configuration of their network and server systems. Gateway Server System...
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Company: BioMerieux SA Date of Enforcement Report: 8/18/2021 Class II PRODUCT MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results by transferring, storing, and displaying medical device data. Recall Number: Z-2225-2021 REASON Software anomaly – Under certain conditions, unwanted alterations to results could be applied when...
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Company: Caption Health Date of Enforcement Report: 7/28/2021 Class II PRODUCT Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873), UDI: (01)00860003586303(10)1.2.0) Recall Number: Z-2111-2021 REASON The firm is aware of a issue with ultrasound software that results in unintended video frames being included. This could lead to an incorrect...
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Company: Respironics California, LLC Date of Enforcement Report: 7/28/2021 Class I PRODUCT Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, chronic respiratory...
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This July 2021 Standards Navigator Report content is only available to Standards Navigator subscribers. See our Subscribe page for information on subscriptions. SoftwareCPR® Standards Navigator provides information and tools related to standards that play a significant role in health software and software intensive medical devices.  In addition to information on existing standards, our report keeps you...
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As the use of Artificial Intelligence (AI) and machine learning methods expand in medical devices and HealthIT software, an oft asked question is whether the data sets used for training should be retained as part of the design history file (DHF) or other long term storage mechanisms.  SoftwareCPR partners Alan Kusinitz, Sherman Eagles, John Murray,...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 7/14/2021 Class II PRODUCT ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000 Recall Number: Z-2029-2021 REASON Software error VE10B -In case of a fault within the drivetrain of an axis and while performing a stepped peripheral imaging...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 5/5/2021 Class II PRODUCT Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese...
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This January 2021 Standards Navigator Report content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. SoftwareCPR® Standards Navigator provides information and tools related to standards that play a significant role in health software and software intensive medical devices. In addition to information on existing standards, SoftwareCPR Standards Navigator keeps you...
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Company: Philips North America, LLC Date of Enforcement Report: 1/20/2021 Class II PRODUCT Emission Computed Tomography System Image Process System – Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. Recall Number: Z-0852-2021 REASON A software defect that has the potential to result in image...
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This December 2020 Standards Navigator Report content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. SoftwareCPR Standards Navigator Report provides information and tools related to standards that play a significant role in health software and software intensive medical devices. In addition to information on existing standards, SoftwareCPR Standards...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 11/11/2020 Class II PRODUCT ARTIS Icono Interventional Fluoroscopic X-Ray system – Product Usage: Intended Use: ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Recall Number: Z-0400-2021...
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Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report: 9/2/2020 Class II PRODUCT E.cam or Symbia systems that use foresight detectors – Product Usage: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to...
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Company: Capso Vision, Inc. Date of Enforcement Report: 7/15/2020 Class II PRODUCT The CapsoCam Plus (SV-3); Device Common Name: System, Imaging, Gastrointestinal, Wireless, Capsule; Catalog Number 2795 – Product Usage: intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small...
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Company: Tomtec Imaging Systems Gmbh Date of Enforcement Report: 7/15/2020 Class II PRODUCT TOMTEC-ARENA TTA2 (sw version no. 2.20 and lower) Picture archiving and communications system. Recall Number: Z-2496-2020 REASON The firm discovered a software issue associated with the Image-Com module/clinical application package (CAP) interface for 3D application in the ARENA software, where measurements from...
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Company: Shanghai United Imaging Healthcare Co., Ltd. Date of Enforcement Report: 7/8/2020 Class II PRODUCT uCT 530 Computed Tomography X-Ray System Recall Number: Z-2472-2020 REASON Two issues were identified with the computed tomography x-ray system including a service function which may cause false marking of a bad channel resulting in ring artifacts, and potential intermittent...
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Company: Agfa N.V. Date of Enforcement Report: 6/10/2020 Class II PRODUCT AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Type number: 6010/200 – Product Usage: DR 800: Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following anatomies/procedures: positioning fluoroscopy procedures, gastro-intestinal examinations,...
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Company: Medtronic Navigation, Inc. Date of Enforcement Report: 6/10/2020 Class II PRODUCT Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS License or StealthStation S8 Software with Stealth DBS License and O-arm Imaging System utilizing the auto-registration (fiducial- less) workflow used in combination during a DBS (deep brain stimulation)...
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Company: Boston Scientific Corporation Date of Enforcement Report: 5/7/2020 Class II PRODUCT iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System Recall Number: Z-1804-2020 REASON Certain iLab Polaris Systems which were upgraded with a previous 2.10 software version (disk batch 629774) contained a bug in which only the True Color Secondary Capture (SC) format will...
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Company: Synaptive Medical Inc. Date of Enforcement Report: 4/29/2020 Class II PRODUCT ClearCanvas RIS/PACS Recall Number: Z-1758-2020 REASON A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis. RECALLING FIRM/MANUFACTURER Synaptive Medical Inc. on 2/26/2020. Voluntary:  Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE...
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Company: Shanghai United Imaging Healthcare Co., Ltd. Date of Enforcement Report: 4/22/2020 Class II PRODUCT Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R001.3.0.0.750505, Rx Only, CE 0197, UDI: (01)06971576832026 – Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization,...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 3/25/2020 Class II PRODUCT Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Artis Q Floor, Model No. 10848280; Artis Q zeego, Model No. 10848283 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and...
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Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report: 8/28/2019 Class II PRODUCT ACUSON NX2 Diagnostic Ultrasound System, Model # 11284381, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869030005 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver),...
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Company: Philips North America, LLC Date of Enforcement Report: 8/14/2019 Class II PRODUCT Philips Azurion systems with software version R1.2 -Interventional Fluoroscopic X-ray system as follows: Azurion 3 M12, Azurion 3 M15, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20 Models: 722063, 722064, 722067, 722068, 722078, 722079. Product Usage: The Azurion...
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Company: Philips Ultrasound Inc Date of Enforcement Report: 8/14/2019 Class II PRODUCT Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Models EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIZ CVx, Affiniti 30, Affiniti 50, and Affiniti 70. Product Usage: The intended use of the EPIQ, EPIQ 5, EPIQ...
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Company: Elekta, Inc. Date of Enforcement Report: 7/24/2019 Class II PRODUCT Elekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment...
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Company: GE Healthcare, LLC Date of Enforcement Report: 7/3/2019 Class II PRODUCT Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001 Product Usage: Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored,...
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Company: GE Healthcare, LLC Date of Enforcement Report: 6/26/2019 Class II PRODUCT LVivo EF app on Vscan Extend. Sold under the following product names: a. Vscan Extend Dual DICOM, Model Numbers H41212ZA, H41212RN; b .Vscan Extend Dual USB, Model Number H41212RK; c. Vscan Extend Dual Wi-Fi, Model Numbers H41212YZ, H41212RL; d. Vscan Extend Sector DICOM,...
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Company: Elekta Limited Date of Enforcement Report: 4/17/2019 Class II: PRODUCT Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a...
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Company: GE Healthcare, LLC Date of Enforcement Report: 2/1/2019 Class II PRODUCT GE Healthcare Centricity Universal Viewer Breast Imaging Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and processed. Typical users of...
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Company: Agfa-Gevaert, N.V. Date of Enforcement Report: 1/7/2019 Class II PRODUCT DX-D 600 DIRECT RADIOGRAPHY SYSTEM Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray radiographic images of the skeleton...
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Company: Medtronic Navigation, Inc. Date of Enforcement Report: 12/29/2018 Class II PRODUCT GE Magnetic Resonance System Various GE Magnetic Resonance System on-site software version. Product Usage: Magnetic resonance imaging equipment for general diagnostic use. Recall Number: Z-0693-2019 REASON Possible incorrect software version loaded. RECALLING FIRM/MANUFACTURER GE Healthcare, LLC, Waukesha, WI on 11/15/2018. Voluntary: Firm Initiated...
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Company: Elekta, Inc. Date of Enforcement Report: 12/27/2018 Class II PRODUCT MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery Recall Number: Z-0686-2019 REASON If a Setup field (CT, kV, MV or MVCT) is created by COPYING a treatment field or another setup...
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Company: GE Healthcare, LLC Date of Enforcement Report: 11/2/2018 Class II: PRODUCT Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation displays medical images (including mammograms) and data from various imaging sources. Centricity Universal Viewer with PACS-IW foundation 6.0.x displays medical images (including mammograms) and data from various imaging sources. Recall Number: Z-0374-2019 (5.0.x), Z-0375-2019 (6.0.x) REASON...
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Company: Agfa Healthcare NV Date of Enforcement Report 10/17/2018 Class II: PRODUCT Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) when deployed as PACS Recall Number: Z-0101-2019 REASON Adding an additional comparison study to the Clinical Side Bar in the Enterprise Imaging Diagnostics Desktop, can result in a change of the sort order of the...
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Company: Vision RT LtdDate of Enforcement Report 10/10/2018 Class lI: PRODUCT Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. Part number: V000172 Recall Number:...
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Company: Swissray Date of Enforcement Report 10/3/2018 Class lI: PRODUCT ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging. Serial Numbers within U.S.A commerce – 1302002, 1302003, 1302005, 1302009, 1302011, 1402001, 1402002, 1402006, 1402007, 1402008, 1402009, 1402011, 1402012, 1402015, 1502001, 1502002, 1502004, 1502005, 1502006, 1502007, 1602001, 1602002, 1602003, 1602005,...
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Company:Mobius Imaging, LLC.. Date of Enforcement Report 9/26/2018 Class II: PRODUCT AIRO Mobile CT System Model # Mobi CT-32 Recall Number: Z-2991-2018 REASON The Tube Current Modulation feature (Modulated Scans) is not working in AIRO systems with software version 2.0.0.0, and operators would not be able to detect this fault until after a scan is...
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Company:Mobius Imaging, LLC..Date of Enforcement Report 9/26/2018 Class lI: PRODUCT AIRO Mobile CT System Model # Mobi CT-32 Recall Number: Z-2991-2018 REASON The Tube Current Modulation feature (Modulated Scans) is not working in AIRO systems with software version 2.0.0.0, and operators would not be able to detect this fault until after a scan is completed.....
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Company:Canon Medical System, USA, INC. Date of Enforcement Report 9/12/2018 Class II: PRODUCT Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application intended to be used to process digital image files. Recall Number: Z-2964-2018 REASON It was found when an operator performs a radiography using the wireless flat panel detector...
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Company:Canon Medical System, USA, INC.Date of Enforcement Report 9/12/2018 Class lI: PRODUCT Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application intended to be used to process digital image files. Recall Number: Z-2964-2018 REASON It was found when an operator performs a radiography using the wireless flat panel detector (FPD),...
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Company: Ortho Kinematics, Inc Date of Enforcement Report 8/29/2018 Class II: PRODUCT Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application intended to be used to process digital image files. Recall Number: Z-2882-2018 REASON Ortho Kinematics Inc. sent a Notice of Correction to Released Testing Results, Radiological Read Report for...
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Company:Ortho Kinematics, IncDate of Enforcement Report 8/29/2018 Class lI: PRODUCT Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application intended to be used to process digital image files. Recall Number: Z-2882-2018 REASON Ortho Kinematics Inc. sent a Notice of Correction to Released Testing Results, Radiological Read Report for the Vertebral...
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