By

Jordan Pate
Zeller Power Products, LLC Product: Medical Device Date: 5/9/19 CMS Number: 570909 The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations, Zeller Power Products, LLC., located at 6585 Arville Street, Suite A, Las Vegas, NV, from November 6 – 9, 2018. During the inspection, an FDA investigator...
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Rechargeable Power Energy North America, LLC Product: Medical Device Date: 5/9/19 CMS Number: 570911 The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations, Rechargeable Power Energy North America, LLC located in Las Vegas, Nevada, from November 5 – 9, 2018. During the inspection, an FDA investigator determined...
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Company: Viewray, Inc. Date of Enforcement Report: 5/8/2019 Class II PRODUCT MRIdian Linac Radiation Therapy System, Model 20000. Recall Number: Z-1251-2019 REASON A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur. RECALLING FIRM/MANUFACTURER Viewray, Inc on 3/18/2019. Voluntary:  Firm Initiated recall is ongoing. VOLUME OF PRODUCT...
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Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report: 5/8/2019 Class II PRODUCT SOMATOM Definition Edge, Model Number 10590000 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. Recall Number: Z-1245-2019 SOMATOM Edge Plus, Model Number 10267000 Recall Number: Z-1246-2019 SOMATOM Definition...
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Company: Fenwal Inc. Date of Enforcement Report: 5/1/2019 Class II PRODUCT Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled as the following kits: 1. AT-1 sets and kits (9005104 AT-1 Autotransfusion set, 9108504 ATF 120 Fast Start Kit, and 9108494 ATF 40 Fast Start Kits); 2. AT-3 Autotransfusion sets and kits (Part 9005444 AT-3 set,...
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Company: Ortho-Clinical Diagnostics Date of Enforcement Report: 5/1/2019 Class II PRODUCT VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 Product Usage: The VITROS XT 7600 Integrated System is intended for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides,...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 5/1/2019 Class II: PRODUCT Siemens Digital Linear Accelerators of type: ARTISTE MV System MEVATRON M2/Primus Mid-Energy PRIMUS PRIMUS HI ONCOR Impression ONCOR Impression Plus ONCOR Avant Garde ONCOR Expression ARTISTE, ONCOR, and PRIMUS running the following: Control Console from software version 13.0.302 and higher; Control...
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Company: Brainlab AG Date of Enforcement Report: 5/1/2019 Class II: PRODUCT RT Elements Software revisions of the RT Elements applications have a specific software version number. Specifically the following RT Elements applications/versions are affected: – Cranial SRS 1.0.0 and 1.5.0 – Spine SRS 1.0.0 and 1.5.0 – Multiple Brain Mets SRS 1.5.0 – RT QA...
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Company: St Jude Medical Inc. Date of Enforcement Report: 5/1/2019 Class II: PRODUCT St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product Usage: The St. Jude Medical Confirm Rx insertable cardiac monitor (ICM) is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network (PCN). It is indicated...
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Company: Gyrus ACMI, Inc. Date of Enforcement Report: 4/24/2019 Class II: PRODUCT Olympus Diego Elite Console MDCONS 100; Recall Number: Z-1178-2019 Part No BB2000SA; Recall Number: Z-1179-2019 Part Number: BB4000SS; Recall Number: Z-1180-2019 Part No: BB4000SC; Recall Number: Z-1181-2019 Product Number:BB4040SS; Recall Number: Z-1182-2019 Product Number: BB4040SC; Recall Number: Z-1183-2019 Product Number: BB4040XS; Recall Number:...
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Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 4/24/2019 Class II: PRODUCT syngo Lab Data Manager System – Product Usage: syngo Lab Data Manager is a clinical system that assists medical laboratory professions with pre-analytic and post-analytic functions. It works in conjunction with multiple instruments, the laboratory information system (LIS) and the Siemens Healthcare...
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Company: Topcon Medical Systems, Inc. Date of Enforcement Report: 4/24/2019 Class II: PRODUCT IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon devices without controlling or altering the functions...
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Company: Brainlab AG Date of Enforcement Report: 4/24/2019 Class I: PRODUCT Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Version 3.0 ) Intended Use The Spine & Trauma Navigation System is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. Recall Number: Z-1082-2019 REASON...
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Company: Steris Corporation Date of Enforcement Report: 3/20/2019 Class II: PRODUCT AMSCO 3000 Series Washer/Disinfector Model # 3052 Recall Number: Z-0995-2019 REASON The software in the systems may not process the cycle originally intended. This could result in damage to the various medical devices and instruments processed in the washer/disinfector or potential for inadequate cleaning...
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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: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 4/17/2019 Class II: PRODUCT syngo.via syngo.CT Cardiac Function, Model Number 10496180 Product Usage: Syngo.CT Cardiac Planning and syngo CT. Cardiac Function are image analysis software packages for evaluating cardiac CT angiography (CTA) volume sets. The software packages are designed to support the physician in determining...
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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: Draegar Medical Systems, Inc. Date of Enforcement Report: 4/13/2019 Class II: PRODUCT Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in...
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Company: Advanced Bionics, LLC Date of Enforcement Report: 4/10/2019 Class II: PRODUCT Naida CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model Cl-5260-140; and Velvet Black, Model Cl-5260-150. Recall Number: Z-1083-2019 Naida CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model Cl-5245-140; and Velvet Black, Model Cl-5245-150. Recall Number: Z-1084-2019 Naida...
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Company: Beckman Coulter Inc. Date of Enforcement Report: 4/10/2019 Class II: PRODUCT The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285. Recall Number: Z-1077-2019 REASON When racks are...
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Company: Becton Dickinson & Co. Date of Enforcement Report: 4/3/2019 Class II: PRODUCT BD Synapsys Laboratory Solutions Catalog Number:444150 Product Usage: BD Synapsys is a laboratory software solution providing data management and workflow management functionality across clinical diagnostic activities. The software integrates operational and clinical data points from laboratory hardware, with patient data received from...
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In January 2018, the U.S. Food and Drug Administration (FDA) issued a safety communication to alert health care providers and patients about a potential problem in the charging circuitry of the Zoll LifeVest 4000, which had the potential to prevent it from delivering a life-saving shock to patients. If the message “Call for Service –...
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Company: Elekta, Inc. Date of Enforcement Report: 2/8/2019 Class II: PRODUCT Monaco Radiation Treatment Planning (RTP) System Recall Number: Z-0965-2019 REASON If Improve Target Dose was chosen as an optimization model in a previous treatment session, Monaco will automatically use this optimization model again when proceeding with the online plan adaptation of a completion plan...
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Company: Shimadzu Medical Systems Usa Com Date of Enforcement Report: 3/6/2019 Class II: PRODUCT DIGITAL ANGIOGRAPHY SYSTEM: This system is intended to be used for radiologic visualization of the heart, blood vessels or lymphatic system during or after injection of a contrast medium. It is to be used in the diagnosis of the circulatory vascular...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 3/6/2019 Class II: PRODUCT Sensis Vibe System, Model Number 11007642, with software version VD10B. Recall Number: Z-0936-2019 REASON A software error may result in a system crash. The system must be restarted before the clinical procedure can be continued. The ablation treatment must be performed...
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Company: Physio-Control Inc Date of Enforcement Report: 3/6/2019 Class I: PRODUCT LIFEPAK 15 Monitor/Defibrillator Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols. The LP15 monitor/defibrillator is intended for use by trained medical personnel in...
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Company: Stryker Sustainability Solutions Date of Enforcement Report: 3/5/2019 Class II: PRODUCT Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and, shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses. Intended for use in...
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Company: Baxter Healthcare Corporation Date of Enforcement Report: 2/27/2019 Class II: PRODUCT AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal dialysis. Recall Number: Z-0849-2019 Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended for automatic...
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Company: Leica Microsystems, Inc. Date of Enforcement Report: 2/27/2019 Class II: PRODUCT PROVEO 8 Ophthalmic Microscope System optical instrument for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment. Recall Number: Z-0838-2019 REASON The observed issues can lead to unexpected...
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Company: Elekta, Inc. Date of Enforcement Report: 2/8/2019 Class II: PRODUCT MOSAIQ Oncology Information System and Sequencer MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed. Recall Number: Z-0821-2019 REASON There...
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Company: Medtronic, Inc. Date of Enforcement Report: 1/17/2019 Class I: PRODUCT Medtronic’s Dual Chamber Implantable Pulse Generators (IPGs) are implanted cardiac pacemakers used to provide stimulation to increase heart rate in patients with a slow heart rhythm (bradycardia) or no heart rhythm. The pulse generator is the small implanted unit containing the battery and other...
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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: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Date of Enforcement Report: 2/1/2019 Class II PRODUCT MEDTRONIC CARELINK 2090 programmer Recall Number: Z-0795-2019 REASON There is an error in how the programmer calculates and displays the remaining longevity value during a period of time (up to 2 years) prior to the device reaching its...
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Company: GE Healthcare, LLC Date of Enforcement Report: 2/6/2019 Class II PRODUCT Revolution CT systems with the SmartStep Option. The system is intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications. Recall Number: Z-0776-2019 REASON On the Revolution CT systems equipped with the SmartStep Option, the Z location displayed on image annotation...
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Company: NEUSOFT MEDICAL SYSTEMS IMP & EX Date of Enforcement Report: 2/5/2019 Class II PRODUCT NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY...
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Company: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Date of Enforcement Report: 2/1/2019 Class II: PRODUCT MEDTRONIC CARELINK 2090 programmer Recall Number: Z-0795-2019 REASON There is an error in how the programmer calculates and displays the remaining longevity value during a period of time (up to 2 years) prior to the device reaching its...
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Company: GE Healthcare, LLC Date of Enforcement Report: 2/6/2019 Class II: PRODUCT Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Recall Number: Z-0776-2019 REASON On the Revolution CT systems equipped with the SmartStep Option, the Z location displayed on image annotation...
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Company: NEUSOFT MEDICAL SYSTEMS IMP & EX Date of Enforcement Report: 2/5/2019 Class II: PRODUCT NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY...
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Company: Becton, Dickinson and Company, BD Biosciences Date of Enforcement Report: 2/1/2019 Class III: PRODUCT BD FACSLyric(TM) 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878 BD FACSLyric(TM) is a high-performance flow cytometer designed to support both routine clinical analysis and research for the identification, quantification, and characterization of cells in support of cell...
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Company: Radiometer America Inc Date of Enforcement Report: 2/5/2019 Class II: PRODUCT Product: ABL800 FLEX with Crea. The ABL800 with Crea is available in the following configurations: ABL817, ABL827 and ABL837. ABL800 Series Ref. 393-803, 393-804, 393-805, 393-806, 393-820, 393-821, 393-825, 393-826, 393-835, 393-836, 393-844, 393-845. Recall Number: Z-0801-2019 REASON From three incidents in Denmark...
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Datascope Corporation Product: Medical Device Date: 2/6/19 The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations at 1300 Macarthur Blvd., Mahwah, NJ, from July 30, 2018 through October 3, 2018. During the inspection, FDA investigators determined that your firm is a of intra-aortic balloon pumps (IABPs) and Cardiosave...
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Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 1/29/2019 Class II PRODUCT Atellica IM 1300 Analyzer; In-vitro diagnostic testing of clinical specimens; Siemens Material Number (SMN): 1066001 Product Usage: The Atellica Solution is a multi-component system for in-vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of...
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FDA posted a Stryker announcement today that the company is launching a voluntary field action (VFA) on specific units of the LIFEPAK 15 Monitor/Defibrillators. The company is notifying certain LIFEPAK 15 customers of an issue that may cause the device to lock up after a defibrillation shock is delivered. The lock-up condition is defined as...
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Company: Varian Medical Systems, Inc. Date of Enforcement Report: 1/24/2019 Class II PRODUCT Eclipse(TM) Treatment Planning System with Proton Convolution Superposition algorithm license only The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon,...
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Company: Stryker Sustainability Solutions Date of Enforcement Report: 1/23/2019 Class II PRODUCT BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. Recall Number: Z-0766-2019 REASON Stryker’s Sustainability Solutions division (SSS) has...
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Company: Philips Medical Systems Nederlands Date of Enforcement Report: 1/8/2019 Class II PRODUCT Ingenia Elition S, Ingenia Elition X Recall Number: Z-0694-2019 REASON During automatic tabletop movement, pressing and holding the Stop Table button may lead to an unexpected restart of the table movement. RECALLING FIRM/MANUFACTURER Philips Medical Systems Nederlands, Best, Netherlands on 12/3/2018. Voluntary:...
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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: Hologic, Inc. Date of Enforcement Report: 12/27/2018 Class II PRODUCT I-View Contrast Enhanced Digital Mammography, ASY-08109 Recall Number: Z-0685-2019 REASON Calibration issue not possible to visualize contrast uptake in the subtracted mammography images RECALLING FIRM/MANUFACTURER Hologic, Inc., Danbury, CT on 12/6/2018. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 337 units...
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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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