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

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...Read More

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 De Novo process, they are taking the more formal step of agency rule-making regarding the topic as well....Read More

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...Read More

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...Read More

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...Read More

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:...Read More

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....Read More

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...Read More

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...Read More

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...Read More

(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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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....Read More

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...Read More

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...Read More

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...Read More

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...Read More

Company: Mevion Medical Systems, Inc. Date of Enforcement Report: 7/1/2020 Class II PRODUCT MEVION S250i, MEVION S250; Proton Radiation Treatment System Recall Number: Z-2406-2020 REASON Couch Correction moves sent after using a 3D CT scan are partially lost if the previous correction sent or recorded had some of the Couch Correction checkboxes turned off. RECALLING...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report: 7/1/2020 Class II PRODUCT Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software Release – Product Usage: VERICIS is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including images,...Read More

Company: Suntech Medical, Inc. Date of Enforcement Report: 7/1/2020 Class II PRODUCT Oscar 2, Model 250 System Recall Number: Z-2429-2020 REASON The device display, when activated, can show an incorrect decimal point when the blood pressure reading is a three-digit number and the unit of measure is set for mmHg. RECALLING FIRM/MANUFACTURER Suntech Medical, Inc....Read More

Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report: 6/17/2020 Class II PRODUCT RayStation 4.0 to RayStation 5 Service Pack 2 – Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. Recall Number: Z-2339-2020 REASON Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS)...Read More

Company: Elekta Limited Date of Enforcement Report: 6/17/2020 Class II PRODUCT Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571 Recall Number: Z-2297-2020 REASON In TSM (Treatment Session Manager) Motion Monitoring workflows, under certain conditions there can be a mismatch between the contour data overlay with respect to the motion monitoring images...Read More

Company: Philips Healthcare Informatics, Inc. Date of Enforcement Report: 6/17/2020 Class II PRODUCT IntelliSpace PACS 4.4, Product number 837507 – Product Usage: intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. Recall Number: Z-2338-2020 REASON Images may potentially become corrupt while using the system. RECALLING FIRM/MANUFACTURER Philips...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 6/10/2020 Class II PRODUCT ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600 Recall Number: Z-2257-2020 REASON Using Quantification Application (QVA/QCA) on DSA images may lead to a failure in vessel detection or...Read More

Company: Hill-Rom, Inc. Date of Enforcement Report: 6/10/2020 Class II PRODUCT Centrella Smart+ Bed, Catalog Number P7900 Recall Number: Z-2246-2020 REASON The Bed Exit System may fail to send a remote alert through the nurse call system if a remote alert was previously sent and cancelled at the in-room nurse call wall unit. RECALLING FIRM/MANUFACTURER...Read More

Company: Agfa N.V. Date of Enforcement Report: 6/10/2020 Class II PRODUCT AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Type number: 6010/200 – Product Usage: DR 800: Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following anatomies/procedures: positioning fluoroscopy procedures, gastro-intestinal examinations,...Read More

Company: Insulet Corporation Date of Enforcement Report: 6/10/2020 Class II PRODUCT Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number PT000010 M/D: INT1D001MG – Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin. Recall Number: Z-2164-2020 REASON After the device...Read More

Company: Spacelabs Healthcare, Inc. Date of Enforcement Report: 6/10/2020 Class II PRODUCT Xhibit Central, Model No. 96102 – Product Usage: intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters. Recall Number: Z-2261-2020 REASON The firm received...Read More

Company: Intuitive Surgical, Inc. Date of Enforcement Report: 6/10/2020 Class II PRODUCT da Vinci SP surgical system Recall Number: Z-2260-2020 REASON Intuitive has become aware that the da Vinci SP system may trigger a mechanical vibration of the instrument tips and endoscope due to a software anomaly. This issue has the potential to occur only...Read More