News Archives

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,...

May

Recall – IVD software error detection inadvertently disabled

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,...

May

Recall – Digital Linear Accelerator software error may lead to injury

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...

May

Recall – Radiation treatment planning app may lead to incorrect dose calculation

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...

May

Recall – Insertable Cardiac Monitor unable to pair with mobile app

April 26, 2019Brian PateNews

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...

Apr

Quantitative Imaging

In April 2019, FDA released a draft guidance providing manufacturers and FDA staff with detailed recommendations on assessing the technical performance of quantitative imaging devices and how the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...

Apr

SoftwareCPR April 2019 Newsletter

April 26, 2019Brian PateNews

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.

Apr

Recall – Surgical system may inadvertently permit RF energy release

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:...

Apr

Recall – Lab data management system software issues

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...

Apr

Recall – Patient data system may display incorrect information

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...

Apr

Recall – Spine & Trauma Navigation System software error

April 20, 2019Jordan PateNews

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...

Apr

Recall – Washer/Disinfector software executes different cleaning cycle than selected

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...

Apr

Recall – X-ray system loses imaging function under certain conditions

April 18, 2019Jordan PateNews

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...

Apr

Recall – CT Image analysis software algorithm error

April 17, 2019Jordan PateNews

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...

Apr

Recall – Image guided radiation therapy system instructions for use unclear

April 17, 2019Jordan PateNews

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...

Apr

Recall – Patient monitor software with cybersecurity vulnerabilities

April 13, 2019Jordan PateNews

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...

Apr

Classification of Accessories

April 11, 2019Alan KusinitzNews

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...

Apr

Recall – Cochlear implant sound processor loaded with incorrect firmware

April 10, 2019Jordan PateNews

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...

Apr

Recall – Immunoassay system software scheduling error leads to incorrect results

April 10, 2019Jordan PateNews

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...

Apr

FDA publishes Unmet Medical Device Needs for Rare Diseases

April 6, 2019Jordan PateNews

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...

Apr

FDA Regulation of AI

April 4, 2019Alan KusinitzNews

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...

Apr

Recall – Laboratory data management software error

April 3, 2019Jordan PateNews

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...

Mar

CBER Finalizes Standards Guidance

March 25, 2019Brian PateNews

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...

Mar

FDA Safety Communication on Cybersecurity Vulnerabilities

March 21, 2019Alan KusinitzNews

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,...

Mar

FDA Exempts Flow Cytometry from 510(k) requirements

March 14, 2019Brian PateNews

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...

Mar

FDA qualifies software module biomarker test

March 14, 2019Brian PateNews

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...

Mar

FDA Medical Device Development Tool (MDDT) Qualification

March 14, 2019Brian PateNews

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...

Mar

SoftwareCPR March 2019 Newsletter

March 7, 2019Brian PateNews

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.

Mar

FDA Safety Communication on Software Update for Cardioverter Defibrillator failure

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 –...

Mar

Recall – Radiation treatment planning system software error

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...

Mar

Recall – Digital angiography system application terminates after certain steps

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...

Mar

Recall – Hemodynamic system software error results in system crash

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...

Mar

Recall – Defibrillator system monitor goes blank after use