Company: Abbott Laboratories Inc. (St Jude Medical) Date of Enforcement Report: 6/5/2019 Class II PRODUCT TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part Numbers: 600043767 (China), 100154367 (Global), 100154368 (SWAP) Recall Number: Z-1493-2019 REASON In reported cases, the device log on the TactiSys Quartz Equipment operating on Software Version 1.7.0 fills the...Read More

Company: Change Healthcare Israel Ltd. Date of Enforcement Report: 6/5/2019 Class II PRODUCT Horizon Cardiology Hemo: Software version 11.x and 12.x Recall Number: Z-1489-2019 Software version 13.x Recall Number: Z-1490-2019 REASON Users are not notified of procedure medication discrepancies between the Vitals and Meds, the Procedure Notes and Patient Common Data screens in Horizon/McKesson Cardiology...Read More

Company: Beckman Coulter Inc. Date of Enforcement Report: 5/29/2019 Class I PRODUCT UniCel DxH 900 Coulter Cellular Analysis System, REF number C11478 Product Usage: Note: The DxH 900 hematology analyzer is CLIA categorized under document CR180294 and is currently marketed as a member of the instrument family of the DxH 800 cleared under K140911, per...Read More

Company: Neusoft Medical Systems Co., Ltd. Date of Enforcement Report: 5/29/2019 Class II PRODUCT NeuViz 64 Multi-slice CT Scanner System Product Usage: The 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 transmission data is reconstructed by...Read More

Company: KaVo Dental Technologies LLC Date of Enforcement Report: 5/29/2019 Class II PRODUCT DEXIS Titanium Intraoral Sensor Product Usage: The DEXIS Titanium Intraoral Sensor is a USB-driven sensor which is intended to acquire dental intraoral radiographic images. The DEXIS / KaVo sensor shall be operated by healthcare professionals, who are educated and competent to perform...Read More

Company: Elekta Instrument AB Date of Enforcement Report: 5/29/2019 Class II PRODUCT Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning. Recall Number: Z-1412-2019 REASON The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume. RECALLING FIRM/MANUFACTURER Elekta Instrument AB...Read More

Company: Roche Diagnostics Corporation Date of Enforcement Report: 5/29/2019 Class II PRODUCT Cobas infinity central lab IT solution Material Number: 07154003001 Calculator/Data Processing Module, For Clinical Use Recall Number: Z-1368-2019 REASON Using the following versions of cobas infinity software (2.0 thorough 2.5), there is a potential where the results from the first sample subsequent to...Read More

Company: Philips North America, LLC Date of Enforcement Report: 5/22/2019 Class II: PRODUCT SureSigns VS3 NBP, Product Number 863069. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature). Recall Number: Z-1317-2019 SureSigns VS3 NBP Temp, Product Number 863070. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature). Recall Number: Z-1318-2019 SureSigns...Read More

Company: Becton Dickinson & Co. Date of Enforcement Report: 5/22/2019 Class II: PRODUCT BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Veritor System Test Devices. Catalog Number: 256066 Recall Number: Z-1313-2019 BD Veritor System Reader -In Vitro Diagnostic for use with BD Veritor System Test Kit Devices Catalog Number: 256055 Recall...Read More

Company: Abbott Gmbh & Co. KG Date of Enforcement Report: 5/22/2019 Class II: PRODUCT Abbott Alinity ci-series System Control Module software version 2.5.1; LN 3R70-01 with the following hardware: Level Sensor, Bulk Solution; 04S68-01, Accessory Kit, Alinity I; 03R66-01and 03R66-02 , and Accessory Kit, Alinity c; 03R69-01 and 03R69-02. Product Usage: The Alinity i (LN...Read More

FDA announced the next phase of its Pre-Cert Test Plan implementation. Pre-Cert refers to the the pre-certification program that FDA’s Digital Health unit has been piloting. The program targets SaMD devices only at this time. This next phase seeks SaMD companies, willing to volunteer, that foresee a De Novo request or 510(k) submission within the...Read More

Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 5/15/2019 Class II PRODUCT Atellica IM 1300 Analyzer, Material Number 11066001; Recall Number: Z-1299-2019 Atellica IM 1600 Analyzer, Material Number 11066000; Recall Number: Z-1300-2019 Atellica Sample Handler Prime, Material Number 11069001; Recall Number: Z-1301-2019 REASON There were multiple issues identified in the system software which required...Read More

Company: Medtronic Inc. Date of Enforcement Report: 5/15/2019 Class II: PRODUCT Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices. Recall Number: Z-1282-2019 REASON The application may be closed by the operating system without alerting the user the app is no longer running or communicating with the transmitter resulting in the...Read More

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...Read More

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...Read More

A 2015 article providing a review of the factors that contribute to a potentially insecure environment, together with the identification of the vulnerabilities, and why these vulnerabilities persist and what the solution space should look like.Read More

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...Read More

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...Read More

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,...Read More

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,...Read More

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...Read More

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...Read More

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...Read More

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...Read More

John F. Murray, Jr, will be teaching at our June 4-6, 2019, FDA and 62304 Software course in Boston. Our course is designed to gain an understanding of how 62304 and other standards can be implemented efficiently and effectively while meeting FDA expectations as well.Read More

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:...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

FDA’s final “Classification of Accessories Distinct from Other Devices; Finalized List of Accessories Suitable for Class” will be posted shortly at https://www.federalregister.gov/documents/2019/04/12/2019-07290/medical-devices-classification-of-accessories-distinct-from-other-devices-finalized-list-of. While this allows for certain accessories for higher class devices to be exempt from premarket notifications, the preamble has a section worth noting as a reminder for medical devices containing software. The preamble...Read More

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...Read More

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...Read More

From late 2015 to 2016, FDA and NCATS/ORDR at NIH conducted a needs assessment to better understand unmet medical device needs for rare diseases; generate meaningful data to inform patients, practitioners, policymakers, and device developers on the needs, barriers, and incentives related to medical device development for rare diseases; and increase public awareness of these...Read More

FDA Regulation of Artificial Intelligence (AI) and Machine Learning in Software as a Medical Device On April 2, 2019, the FDA published a discussion paper “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Discussion Paper and Request for Feedback” that describes the FDA’s foundation for a...Read More

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...Read More

The US FDA Center for Biologics Evaluation and Research (CBER) finalized the December 2017 draft guidance titled “Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research” today.  The guidance makes clear that CBER recognizes the value and proper usage of standards and further encourages the...Read More

Today, the U.S. Food and Drug Administration (FDA) issued a safety communication to alert health care providers and patients about cybersecurity vulnerabilities identified in a wireless telemetry technology used for communication between Medtronic’s implantable cardiac devices, clinic programmers, and home monitors. The wireless telemetry protocol has cybersecurity vulnerabilities because it does not use encryption, authentication,...Read More

US FDA has proposed a new rule to exempt Cytometry instruments used for counting or characterizing cells (a well-understood and mature technology), from premarket notification requirements.  Cytometry instruments used for sorting or collecting cells, and instruments that are used as an automated hematology analyzer, or that perform automated differential cell counts, will still require premarket...Read More

Today FDA qualified the Osirix CDE Software Module biomarker test for use by medical device developers to identify and enroll patients into Traumatic Brain Injury (TBI) studies.  This is the third qualification of a medical device development tool (MDDT) by the FDA, and the first of a software module biomarker test tool type. A biomarker...Read More

Medical Device Development Tool (MDDT) Qualification The US FDA has provided guidance on the methods and approaches to qualify a medical device development tool so that medical device manufacturers or sponsors can use them to support the development and evaluation of medical devices.  The manufacturer is expected to ensure the tool produces “scientifically-plausible measurements” and...Read More

Our March 2019 Newsletter has been published.  Learn of significant regulatory and standards related activity associated medical device software, medical mobile apps, and HealthIT software.  Also you can find dates for upcoming training opportunities.Read More

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 –...Read More

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...Read More

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...Read More

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...Read More