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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: ...
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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...
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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...
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62304 Public Training Course DATES:  September 22-24, 2020 (Registration is limited.  Registration is open through September 17, 2020 as seats remain.) COST: 3 Full Days for $2,100.00 Company Discount:  First two students at full price and then 10% off for any others (up to course size limit) This 62304 Public Training Course provides a clear...
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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...
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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...
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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: 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...
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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....
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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...
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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...
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SoftwareCPR August 2020 Newsletter has been published.  FDA news, regulatory updates, new SoftwareCPR content, software recalls, and software warning letters.
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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....
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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...
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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...
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SoftwareCPR July 2020 Newsletter has been published.  FDA news, regulatory updates, new SoftwareCPR content, software recalls, and software warning letters.
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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...
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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...
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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...
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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...
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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...
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On July 16, 2020, FDA issued 510(k) Approval for AI Imaging Analytics Device HealthMammo, a device manufactured by Zebra Medical Vision Ltd. As reported in the New York Times, HealthMammo is an artificial intelligence (AI) product that analyzes mammograms for suspicious lesions. Radiologists can use the HealthMammo results to prioritize which mammogram images need attention...
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This content is only available to our Premium subscribers.  See our Subscribe page for information on subscriptions.   The agency rule list for Spring 2020, accessible at https://www.reginfo.gov/public, announced that the “Medical Device De Novo Classification Process” rule is in the final rule stage. Although the FDA has previously written a guidance document about the...
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Company: DiaSorin Molecular LLC Date of Enforcement Report: 7/22/2020 Class II PRODUCT MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: is intended for use on the LIAISON¿ MDX instrument for the qualitative detection and differentiation of HSV-1 and HSV-2 present in cerebrospinal fluid (CSF), or cutaneous and mucocutaneous lesion...
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June 17, 2020 Excerpts from a warning letter of interest to software professionals: “During our inspection, our investigators observed specific deviations including, but not limited to, the following… 3. Failure to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data and failure to have adequate controls to prevent omission of...
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Company: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Date of Enforcement Report: 7/15/2020 Class II PRODUCT CareLink SmartSync Device Manager, Model Number 24970A Recall Number: Z-2505-2020 REASON There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features...
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Company: Vitalconnect Inc. Date of Enforcement Report: 7/15/2020 Class II PRODUCT A software graphical user interface intended for use by healthcare professionals to display physiological data collected by the wireless remote monitoring system in healthcare settings. This is a secondary, adjunct patient monitor and is not intended to replace existing standard-of-care patient monitoring. Recall Number:...
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Company: Ra Medical Systems, Inc. Date of Enforcement Report: 7/15/2020 Class II PRODUCT DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer laser ultraviolet light source and delivery system, collectively the DABRA Laser System”. The system is designed to deliver the energy to the surgical site to ablate unwanted material....
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Company: Radiometer Medical ApS Date of Enforcement Report: 7/15/2020 Class II PRODUCT Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI (01)05700693938004. Model 393-800 is available in the following configurations: ABL835, ABL830, ABL827, ABL825, ABL825, ABL820, ABL817, ABL815, ABL810, ABL805 and ABL810 BG only and ABL800Basic. The FlexQ module...
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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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(July 13, 2020) Amy Sellers, of Tampa, FL, USA, has joined SoftwareCPR as a Regulatory Associate.  Amy recently received her J.D. from the University of Florida Levin College of Law. She has experience in regulatory pathway decisions, including analysis of intended use and product claims, as well as analysis of design changes against US regulations...
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Background of the Medical Software Functions Exclusion Most of those in the industry do not question whether the FDA has the authority to regulate software that qualifies as a device. However, there are many intricacies in the definitions of the 21st Century Cures Act – which, in 2016, amended the definition of medical devices in...
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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: Fujifilm Medical Systems U.S.A., Inc. Date of Enforcement Report: 7/8/2020 Class II PRODUCT Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server) Recall Number: Z-2471-2020 REASON Lateromedial (LM) and Lateromedial Oblique (LMO) Orientation Markers may be displayed incorrectly on the 3D TOMO slider bar. In...
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On June 24, 2020, there was an update to the current status of FDA’s MDDT program. CDRH announced a new tool had qualified as MDDT. This is only the sixth tool to qualify since the MDDT Guidance document was finalized in 2017. See the list of qualified tools here: https://www.fda.gov/medical-devices/science-and-research-medical-devices/medical-device-development-tools-mddt.   What is the Medical...
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Company: Baxter Healthcare Corporation Date of Enforcement Report: 7/8/2020 Class II PRODUCT Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only Recall Number: Z-2474-2020 REASON A firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a WiFi connection is not established. RECALLING FIRM/MANUFACTURER Baxter Healthcare Corporation on 6/2/2020. Voluntary:  Firm...
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Company: Ortho Clinical Diagnostics Date of Enforcement Report: 7/8/2020 Class II PRODUCT VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750002979 Recall Number: Z-2480-2020 REASON Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances RECALLING FIRM/MANUFACTURER Ortho Clinical Diagnostics on 7/20/2020....
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Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 7/8/2020 Class II PRODUCT CentraLink Data Management System software version 16.0.2 Siemens Material Number (SMN): 11313246 (2) CentraLink Data Management System software version 16.0.3 Siemens Material Number (SMN): 11314337 Product Usage: are clinical laboratory information modules which consolidate test orders and test results, provide test ordering...
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Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report: 7/1/2020 Class II PRODUCT RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1, 9.0, 9.1, 9.2 Recall Number: Z-2426-2020 REASON It is not obvious that the manual import of a treatment record into RayCare PACS does...
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Company: GE Healthcare, LLC Date of Enforcement Report: 7/1/2020 Class II PRODUCT CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro Recall Number: Z-2424-2020 REASON The CARESCAPE Patient Data Module (PDM) is used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro. If Pace detection...
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Company: Siemens Healthcare Diagnostics Inc Date of Enforcement Report: 7/1/2020 Class II PRODUCT RP500e Handheld Barcode Scanner, Zebra Model: DS4308 – HC0062BZZWW, Siemens Material Number (SMN) 11416778 Recall Number: Z-2432-2020 REASON The scanner is not confirming the integrity of read barcode data using the check-digit when reading Code 39 barcodes. RECALLING FIRM/MANUFACTURER Siemens Healthcare Diagnostics...
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