Company: LivaNova USA Inc Date of Enforcement Report: 11/25/2020 Class II PRODUCT VNS Therapy AspireSR Generator Recall Number: Z-0462-2021 REASON Due to an extra digit being inadvertently added to the serial number of a subset of implantable pulse generators, they become not compatible with therapy programmers with software version 11.0.4. RECALLING FIRM/MANUFACTURER LivaNova USA Inc...Read More

Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 11/25/2020 Class II PRODUCT Atellica IM 1300 Analyzer – Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001 Recall Number: Z-0473-2021 REASON Test Definition scanning may reset custom settings to defaults causing falsely low or...Read More

Company: Fresenius Medical Care Holdings, Inc. Date of Enforcement Report: 11/18/2020 Class II PRODUCT Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343 Recall Number: Z-0439-2021 REASON The device may detect an incorrect Heater Bag volume which may lead to a ‘Supply Bag Line Blocked’ alarm during treatment. This alarm may cause the...Read More

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...Read More

Company: Boston Scientific Corporation Date of Enforcement Report: 11/11/2020 Class II PRODUCT Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application Recall Number: Z-0319-2021 REASON There is potential when a user changes an EGM trace channel with a Manual Pace Threshold test in progress that the newly...Read More

Company: GE Healthcare, LLC Date of Enforcement Report: 11/4/2020 Class II PRODUCT Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 – Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Recall Number: Z-0306-2021 REASON There is a potential for a smudge artifact that could be suspect...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report: 11/4/2020 Class II PRODUCT Merge LIS Recall Number: Z-0289-2021 REASON A defect in the software resulted in medications that are not associated with the patient (i.e., medications that the patient is not currently taking) appearing on their report. RECALLING FIRM/MANUFACTURER Merge Healthcare, Inc. on 1/23/2017. Voluntary:  Firm...Read More

Company: Pentax of America Inc Date of Enforcement Report: 11/4/2020 Class II PRODUCT 9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal), Recall Number: Z-0292-2021 REASON There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient (Patient B)....Read More

Company: Fujifilm Medical Systems U.S.A., Inc. Date of Enforcement Report: 10/28/2020 Class II PRODUCT Synapse PACS Software Version 5.6.1 – Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server. Recall Number: Z-0282-2021 REASON FUJIFILM...Read More

The FDA recently announced the addition of 25 new tools to the Catalog of Regulatory Science Tools to help assess medical devices. CDRH catalogues regulatory science tools on this webpage to help improve the development and assessment of emerging medical technologies. Of the 25 tools added, some items of interest are: Laboratory Accuracy Evaluation of...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 10/21/2020 Class II PRODUCT Artis zee or Artis Q systems (listed below) Product Usage: for single and biplane diagnostic imaging and interventional procedures. System Name/Material Number: Artis Q BIPLANE 10848282 ARTIS Q CEILING 10848281 Artis Q floor 10848280 ARTIS Q ZEEGO 10848283 ARTIS Q.ZEN BIPLANE...Read More

Company: Brainlab AG Date of Enforcement Report: 10/14/2020 Class II PRODUCT Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x Product Usage: intended to be an intra-operative image guided localization system to enable minimally invasive surgery. Recall Number: Z-0056-2021 REASON Brainlab Ultrasound Navigation Software does not support the modification of...Read More

Company: Devicor Medical Products Inc Date of Enforcement Report: 10/14/2020 Class III PRODUCT Neoprobe GDS Control Unit, Model Number NPCU3 Recall Number: Z-0070-2021 REASON It was discovered during a documentation review that China has the software version as v5.01 approved for use in China. The current software version on devices distributed in China since 2011...Read More

Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report: 10/7/2020 Class II PRODUCT Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATOM Force (Model #10742326) SOMATOM Definition As (Model #8098027) SOMATOM Definition Edge (Model #10590000) SOMATOM Definition Flash (Model #10430603) SOMATOM Drive (Model #10431700) SOMATOM Confidence (Model #10590100) SOMATOM Edge Plus (Model...Read More

Company: Blood Bank Computer Systems, Inc Date of Enforcement Report: 10/7/2020 Class II PRODUCT ABO QuickPass Web Portal, Version 1.2.0; ABO QuickPass Web Portal 1.1.0; ABO QuickPass Web Portal 1.0.0 Recall Number: B-0697-2020 REASON Blood Bank software, with a defect or glitch, was distributed. RECALLING FIRM/MANUFACTURER Blood Bank Computer Systems, Inc. on 9/16/2020. Voluntary:  Firm...Read More

SoftwareCPR September 2020 Newsletter has been published.  FDA news, regulatory updates, new SoftwareCPR content, software recalls, and software warning letters.Read More

A German woman died with “ransomware attack” as a contributing factor in preventing her from receiving timely care. Media reports indicate that it may be the first death directly linked to a cyberattack on a hospital.  Apparently the closest hospital was under the ransomware attack and could not receive the emergency patient causing the first...Read More

Company: Inpeco S.A. Date of Enforcement Report: 9/23/2020 Class II PRODUCT FlexLab (FLX) with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Laboratory Automation system – Product Usage: The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to...Read More

Brazil eliminates a premarket approval pathway, instead allowing for premarket notification. Previously, Brazil has had a “Cadastro” pathway to register Class II medical devices and IVDs. This pathway required more extensive documentation (like a technical dossier) for Class II and higher-risk Class I devices. However, on September 18, 2020, the Brazilian regulatory agency, National Health...Read More

Company: Life Technologies Corporation Date of Enforcement Report: 9/23/2020 Class II PRODUCT The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem’s COVID-19 Interpretive Software v1.2 for 7500 RTPCR instruments, includes the assays and controls for a multiplex real-time RT-PCR test for the qualitative detection of RNA from SARS-CoV-2 in upper respiratory specimens and bronchoalveolar lavage specimens...Read More

Company: Medtronic Inc. Date of Enforcement Report: 9/23/2020 Class II PRODUCT The Guardian Connect App CSS7200 iOS – Product Usage: intended for use by patients with a compatible consumer mobile device. Recall Number: Z-2980-2020 REASON As a result of the release of new software version to CareLink Personal website, the IOS app for the Continuous...Read More

Company: Novarad Corporation Date of Enforcement Report: 9/23/2020 Class II PRODUCT NovaPACS Diagnostic Viewer. NovaPACS is a picture archiving and communication system software that retrieves, distributes, and display images and data from different modalities including CT, MR, US, CR/DX, NM, PT, and XA. Recall Number: Z-2956-2020 REASON The firm received a report of an atypical...Read More

Company: SICAT GMBH & CO. KG Date of Enforcement Report: 9/16/2020 Class II PRODUCT SICAT IMPLANT V2.0 Recall Number: Z-2951-2020 REASON A dentist found implant positions are not correctly exported from the implant planning software SICAT IMPLANT V2.0 – for the specific export format CMG.DXD. RECALLING FIRM/MANUFACTURER SICAT GMBH & CO. KG on 7/15/2020. Voluntary: ...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report: 9/16/2020 Class II PRODUCT Merge PACS Recall Number: Z-2944-2020 REASON Measurements done on the Merge PACS generated MPR s may have incorrect measurements. RECALLING FIRM/MANUFACTURER Merge Healthcare, Inc. on 8/6/2020. Voluntary:  Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 125 total units DISTRIBUTION U.S. Nationwide...Read More

Company: CareFusion 303, Inc. Date of Enforcement Report: 9/16/2020 Class I PRODUCT BD Alaris System; Alaris PCA Model 8120; P/N P0000031; Rx Only. Infusion pump for Patient Controlled Analgesia. Recall Number: Z-2882-2020 REASON The Alaris PC unit to display incorrect syringe type and/or syringe sizes. This could potentially result in delays in infusion, under-infusion, or...Read More

Do you have a medical device cleared under Emergency Use Authorization (EUA) during the COVID-19 crisis? Section 564 of the FD&C Act allows the FDA to issue EUAs to otherwise unapproved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents...Read More

The Therapeutic Goods Administration (TGA), the regulatory body for therapeutic goods in Australia, had previously announced that various medical device reforms would be enacted from 2019 through 2024. The transition period was (and still is) set to end on October 31, 2024. However, this summer, TGA announced a delay in the commencement of the medical device...Read More

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...Read More

Company: Canon Medical System, USA, Inc. Date of Enforcement Report: 9/2/2020 Class II PRODUCT System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147 Recall Number: Z-2885-2020 REASON During a procedure, when images were acquired, and these images were transferred to PACS /image archival system, the number of images displayed were not the...Read More

Company: Biosense Webster (Israel), Ltd. Date of Enforcement Report: 9/2/2020 Class II PRODUCT CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module – Product Usage: FGThe intended use of the system is catheter-based cardiac electrophysiological (EP) procedures. The system provides information about the electrical activity of the heart and about catheter location during the procedure....Read More

Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report: 9/2/2020 Class II PRODUCT RayCare, device is stand-alone software – Product Usage: used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care. Recall Number: Z-2899-2020 REASON When performing offline image review in RayCare 2C, RayCare 3A and RayCare 3B...Read More

Company: Precision Valve & Automation, Inc. Date of Enforcement Report: 8/26/2020 Class II PRODUCT PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19 respiratory failure. This motorized device automatically compresses a resuscitator bag to provide air to the lungs of a COVID-19 patient, eliminating the human error and fatigue that...Read More

SoftwareCPR August 2020 Newsletter has been published.  FDA news, regulatory updates, new SoftwareCPR content, software recalls, and software warning letters.Read More

An important lesson from a Warning Letter citing FB Claims: In this Warning Letter to SilveryGuy, dated August 14, 2020, FDA – CDER informed the recipient that they had evaluated the company’s website and Facebook (FB) page. This demonstrates that even social media claims can establish the intended use of a product. Be careful what your...Read More

My Software Is a Medical Device … if that’s you, check out this upcoming webinar.  Our very own John Murray will participate in a webinar on August 25, 2020, and join a roundtable discussion with Bakul Patel, Director, Division of Digital Health at FDA.  Shawnnah Monterrey, CEO @BeanStock Ventures will moderate the discussion. You can...Read More

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...Read More

Company: Ion Beam Applications S.A. Date of Enforcement Report: 8/19/2020 Class II PRODUCT Proteus 235 The Proton Therapy System – Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment...Read More

Company: NeuroLogica Corporation Date of Enforcement Report: 8/19/2020 Class II PRODUCT OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before 05.01.01 – Product Usage: is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck. Recall...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 8/12/2020 Class II PRODUCT SIEMENS Healthineers Luminos dRF Max Model: 10762471- Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. Recall Number: Z-2755-2020 REASON Two software issues (1) Using the override function in case of...Read More

Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 8/12/2020 Class II PRODUCT DCA Vantage Handheld Barcode Scanner – Zebra Model – Model # DS4308 – HC0015BZZWW external accessory to DCA Vantage Analyzer US Recall Number: Z-2747-2020 REASON If DCA Vantage Analyzer is configured to run Code 39 with check digit, the scanner is not...Read More

Company: GE Healthcare, LLC Date of Enforcement Report: 8/12/2020 Class II PRODUCT CARESCAPE ONE, Physiological Patient Monitor – Product Usage: is both a multi-parameter physiological patient monitor and an accessory to a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. Recall Number: Z-2750-2020 REASON CARESCAPE ONE...Read More

Company: Smiths Medical ASD Inc. Date of Enforcement Report: 8/12/2020 Class I PRODUCT CADD Medfusion Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1 Recall Number: Z-2734-2020 REASON Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs. RECALLING FIRM/MANUFACTURER Smiths Medical ASD Inc. on 6/26/2020....Read More

June 11, 2020 Interesting excerpts from a warning letter implicating 820.30: “[A]s part of the Convenience Kit manufacturing process, your firm opens and removes the original packaging of the finished device components, including sterile devices, before assembling, repacking, and relabeling the components together in a finished kit . . . handling such products in an...Read More

List of Recently Added 510(k) Exemptions The table above comes from the Federal Register, and it explains the classification scheme (including new product codes) for the new 510(k) exemptions for Class II devices. Clearly, these five exemptions do not have far-reaching implications. This update from the FDA will likely only be significant to our clients...Read More

SoftwareCPR July 2020 Newsletter has been published.  FDA news, regulatory updates, new SoftwareCPR content, software recalls, and software warning letters.Read More

Electronic submissions to the FDA will soon no longer be optional – this new guidance requires e-submission for many types of submissions. The FDA final guidance document, Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act, was issued on July 15, 2020. Under...Read More

Company: Medtronic Xomed, Inc. Date of Enforcement Report: 7/29/2020 Class II PRODUCT Software 1898072 IPC upgrade v 2.7.3.0 – Product Usage: The IPC system is indicated for the incision/cutting removal, drilling and sawing of soft and hard tissue and bone in surgical procedures. Recall Number: Z-2673-2020 REASON During internal testing execution of the next generation...Read More

Company: Philips North America, LLC Date of Enforcement Report: 7/29/2020 Class II PRODUCT IntelliVue G7m Anesthesia Gas Module, Model no. 866173, Firmware Version 04.12.00, System Codes 453564477391, 453564477401, 866173 Recall Number: Z-2689-2020 REASON The device may experience an interruption of gas measurement due to a firmware issue, ceasing measurement and display of gas levels and...Read More

Company: Sysmex America, Inc. Date of Enforcement Report: 7/29/2020 Class II PRODUCT Sysmex PS-10 Sample Preparation System Catalog number: BQ716341 – Product Usage: is a fully automated, user configurable, open system intended for use to prepare human specimens for subsequent analysis on flow cytometers. Recall Number: Z-2687-2020 REASON Insufficient amount of antibody without an error...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 7/29/2020 Class II PRODUCT Syngo.via RT Image Suite with software versions syngo.via VB30 or VB40 Recall Number: Z-2688-2020 REASON If the user modifies for any reason (e.g. reduction of artifacts) the original image orientation of a standard MR protocol to acquire images in a different...Read More