Company: Cardiac Assist, Inc Date of Enforcement Report: 9/23/2022 Class I PRODUCT Devices Recall Number: Z-1763-2022 REASON Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not display data. RECALLING FIRM/MANUFACTURER Cardiac Assist, Inc VOLUME OF PRODUCT IN COMMERCE 723 units (484 currently in field) DISTRIBUTION US Nationwide...Read More

Company: Zap Surgical Systems Date of Enforcement Report: 9/14/2022 Class II PRODUCT ZAP-X Radiosurgery System Recall Number: Z-1742-2022 REASON Software issue identified in cases of initial patient setup with large (greater-than-or-equal-to 1.5 degrees) rotational deviations, between digitally reconstructed radiographs, and pre-delivery X-ray images. In these cases the transitional alignment algorithm may incorrectly calculate the new...Read More

FDA Issues Draft Guidance on Computer Software Assurance for Production and Quality System Software The U.S. Food and Drug Administration (FDA) issued the new draft guidance: Computer Software Assurance for Production and Quality System Software. Download here: 2022-Guidance-Computer-Software-Assurance This new FDA draft guidance provides recommendations on risk-based assurance activities for computers and automated data processing systems that are...Read More

Company: Boston Scientific Corporation Date of Enforcement Report: 9/1/2022 Class II PRODUCT The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator. Recall Number: Z-1669-2022 REASON There is potential...Read More

Company: Oculus Optikgeraete GMBH Date of Enforcement Report: 9/1/2022 Class II PRODUCT Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye. Recall Number: Z-1672-2022 REASON Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs RECALLING FIRM/MANUFACTURER...Read More

Company: Boston Scientific Corporation Date of Enforcement Report: 9/1/2022 Class II PRODUCT Programmer/Recorder/Monitor (PRM) Recall Number: Z-1669-2022 REASON There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators. RECALLING FIRM/MANUFACTURER Boston Scientific Corporation VOLUME OF...Read More

Company: Aggredyne, Inc. Date of Enforcement Report: 8/26/2022 Class II PRODUCT AggreGuide A-100 Instrument Recall Number: Z-1639-2022 REASON The firm identified a software design issue where the improper shut down of the instrument resulted in speeds.csv file contents of the software version 5.1 being erased. Due to this issue, the target RPM for the assay...Read More

The FDA issued a final guidance entitled “Deciding When to Submit a 510(k) for a Software Change to an Existing Device)” dated October 25, 2017. This guidance clarifies for the industry how to determine which software changes to a 510(k)-cleared device require a new 510(k). It seems to reflect what the FDA has applied in...Read More

Company: Roche Diagnostics Operations, Inc. Date of Enforcement Report: 8/11/2022 Class II PRODUCT cobas e801 Immunoassay Analyzer Recall Number: Z-1515-2022 REASON Software issue resulting in signals and sample test results of Pre-Wash tests being impacted. The following assays are considered impacted by the issue: Anti-HAV2, Anti-HBc IgM, IGF-1, Myogloin, Rubella IgG, and Toxo IgG. RECALLING...Read More

Company: Spacelabs Healthcare, Inc. Date of Enforcement Report: 8/11/2022 CLASS: II PRODUCT Xhibit Telemetry Receiver, Model: 96280 Recall Number: Z-1513-2022 REASON Software related alarm escalation defect occurs after approximately 25 days of continuous use. Technical alarm escalation for the following alarms, signal loss, all leads off, low battery, SpO2 sensor off, and signal interference, does...Read More

Company: St. Jude Medical, Cardiac Rhythm Management Division Date of Enforcement Report: 8/2/2022 Class II PRODUCT Merlin PCS 3650 programmer Model 3330 software Recall Number: Z-1495-2022 REASON There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers. RECALLING FIRM/MANUFACTURER St. Jude...Read More

Company: Sight Diagnostics LTD Date of Enforcement Report: 7/27/2022 Class II PRODUCT Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1 Recall Number: Z-1469-2022 REASON The default reference ranges for MCH, MCHC, and RDW for age group “Child 2-11y” are mixed up and incorrectly displayed on OLO devices running software version 2.63, 2.63.1, and 2.63.1.1. Due...Read More

Company: GE Healthcare, LLC Date of Enforcement Report: 7/25/2022 Class II PRODUCT Centricity PACS Software Version 7.0 SP0.0.4.7 Recall Number: Z-1466-2022 REASON The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams. RECALLING FIRM/MANUFACTURER GE Healthcare, LLC VOLUME OF PRODUCT IN COMMERCE 47 installations...Read More

What are non-device software functions according to the FDA?  The 21st century cures act excluded certain types of software.  The term device, as defined in section 201(h), shall not include a software function that is intended— (A) for administrative support of a health care facility, including the processing and maintenance of financial records, claims or...Read More

Company: Baxter Healthcare Corporation Date of Enforcement Report: 7/22/2022 Class I PRODUCT ABACUS TPN (Total Parenteral Nutrition) Calculation software Recall Number: Z-1376-2022 REASON There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software. RECALLING FIRM/MANUFACTURER Baxter Healthcare Corporation. Voluntary. Firm Initiated. VOLUME OF PRODUCT IN COMMERCE 9 units...Read More

Company: Baxter Healthcare Company Date of Enforcement Report: 7/22/2022 Class I PRODUCT ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: 8300-0167 (Abacus V3.1 CE), 8300-0168 (Abacus V3.1 SE), 8300-0169 (Abacus V3.1 ME), 8300-0191 (Abacus V3.2 CE), 8300-0192 (Abacus V3.2 SE), 8300-0193 (Abacus V3.2 ME), 8300-3391 (Abacus V3.3 CE), 8300-3392 (Abacus V3.3 SE), and 8300-3393...Read More

Company: Baxter Healthcare Corporation Date of Enforcement Report: June 22, 2022 Class: I PRODUCT Abacus Order Entry and Calculation Software Recall Number: Z-1376-2022   REASON There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software. RECALLING FIRM/MANUFACTURER Baxter Healthcare Corporation VOLUME OF PRODUCT IN COMMERCE 9 units DISTRIBUTION...Read More

Company: Stryker Instruments Div. of Stryker Corporation Date of Enforcement Report: 7/21/2022 Class II PRODUCT Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model:10764561 Recall Number: Z-1452-2022 REASON Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a disconnect of its communication...Read More

Company: Becton, Dickinson and Company Date of Enforcement Report: 6/22/2022 Product: Intraosseous Needle Set Kits, Intraosseous Manual Driver Kits, Intraosseous Powered Drivers Reason: Product issues may result in delays in care due to limited or non-functioning intraosseous access or could also lead to needlestick injuries Recalling Firm/Manufactuer: BD (Becton, Dickinson and Company) on 6/22/2022. Voluntary:...Read More

Company: Dynex Technologies, Inc. Date of Enforcement Report: 7/5/2020 Class II PRODUCT DYNEX Agility, Agility Analyzer, Model No. 67000 Recall Number: Z-1222-2022 REASON Control samples aspirated from wrong SmartKit on the Agility. Agility software was updated to v1.4.7 to resolve the issue. This leads to a risk that a control from another assay’s SmartKit will...Read More

Company: Baxter Healthcare Corporation Date of Enforcement Report: 6/30/2022 Class II PRODUCT NaviCare Nurse Call/Voalte Nurse Ca Recall Number: Z-1306-2022 REASON An issue has been identified with Phillips (Emergin) and Longleaf non relay (Connexall, Vocera, Cerner) wireless integrations used with NaviCare/Voalte Nurse Call, software versions 3.9.100 through 3.9.300. Calls placed from a push button call...Read More

FDA will host a webinar to discuss Cybersecurity quality system considerations on Tuesday, June 14, 2022, from 1 p.m. to 2:15 p.m. EDT.  The webinar will focus on the latest and current Cybersecurity Premarket Submissions draft guidance released in April 2022.  This draft guidance replaces the 2018 draft version and is intended to further emphasize the...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 6/6/2022 Class II PRODUCT Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 10765502 10910620 Recall Number: Z-1243-2022 REASON Siemens has become aware of three potential software issues with AXIOM Sensis or Sensis/ Sensis Lite systems. This may lead to a...Read More

Company: Bio-Rad Labratories, Inc. Date of Enforcement Report: 5/28/2022 Class II PRODUCT Sickle Cell Program Resin CD-ROM Recall Number: Z-1208-2022 REASON The problem is with the Bio-Rad VARIANT nbs Sickle Cell Program Resin Update CD-ROM software; Model Number: 250-3020, included in VARIANT nbs Sickle Cell Progam Reorder Pack #250-3000. This CD-ROM software included in specific...Read More

Trying to understand Software Design Verification … A QA’s takeaway on reading the General Principles of Software Validation for the first time. FDA gives guidance in the General Principles of Software Validation guidance document, but in general: Testing at different levels: units, integrated units, software complete Testing types: negative, combinatorial, fault injection, risk controls challenge, boundary, corner cases, stress,...Read More

FDA has released a new draft of Premarket Cybersecurity in Medical Devices:  Quality System Considerations and Content of Premarket Submissions.  Per the scope, this 2022 FDA Premarket Cybersecurity Guidance “is applicable to devices that contain software (including firmware) or programmable logic, as well as software as a medical device (SaMD). The guidance is not limited to devices...Read More

Company: Align Technology Inc Date of Enforcement Report: 01/26/2023 Class II PRODUCT Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001 Recall Number: Z-1017-2023 REASON 3D orthodontic planning software has a defect that leads to an issue where incorrect number of aligners may be produced (less or greater than...Read More

FDA recently posted the following cybersecurity alert: On Tuesday, December 21, 2021, the Cybersecurity and Infrastructure Security Agency (CISA) published a vulnerability medical advisory ICSMA-21-355-01 on the Fresenius Kabi Agilia Connect Infusion System. Successful remote exploitation of these vulnerabilities could allow an attacker to gain access to sensitive information, modify settings, or perform arbitrary actions as an...Read More

When developing medical devices, a manufacturer may have difficulty knowing when (or what) the transition from research phase activities to design controls has begun.  Often this is due to the nature of research itself – one is exploring a concept or design approach that may or may not pan out in the end.  The US...Read More

The US FDA announced on December 21, 2021, a cybersecurity alert for the Fresenius Kabi Agilia Connect Infusion System.  The announcement referenced a Cybersecurity and Infrastructure Security Agency (CISA) publication of a vulnerability disclosure ICSMA-21-355-01 on the Fresenius Kabi Agilia Connect Infusion System. Successful remote exploitation of these vulnerabilities could allow an attacker to gain...Read More

Today, the U.S. Food and Drug Administration (FDA) issued the draft guidance: Content of Premarket Submissions for Device Software Functions. The draft guidance is intended to reflect FDA’s most current thinking on the recommended documentation sponsors should include in premarket submissions for FDA’s evaluation of the safety and effectiveness of device software functions, including both...Read More

“From my 25 years at the agency, I completely understand that FDA CDRH guidance development, approval and publication is complex, time-consuming work. I often said it may be compared to threading 1000 needles simultaneously. It requires significant time and energy from many hard-working, dedicated professionals to even reach the first goal of published draft guidance....Read More

Company: Canon Medical System, USA, INC. Date of Enforcement Report: 10/27/2021 Class II PRODUCT Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A Recall Number: Z-0142-2022 REASON A software problem has been identified which could result in the diagnostic imaging system not proceeding to the next actual scan even though automatic start of the next scan is...Read More

The Medical Device Innovation Consortium (MDIC) recently partnered with the MITRE Corporation, Adam Shostack, and the FDA to host a webinar regarding the soon to be released “Playbook for Threat Modeling Medical Devices.” The playbook was created during a series of bootcamps held by the team over the past year and the webinar provided a...Read More

The FDA CDRH announced the guidance documents they intend to publish in FY2022. They also announced their intention to finalize, withdraw, re-open the comment period, or re-issue a revised draft guidance for 80 percent of draft guidance documents within 3 years of the close of the comment period, and within 5 years of the close...Read More

Company: GE Healthcare, LLC Date of Enforcement Report: 10/27/2021 Class II PRODUCT SIGNA Premier Recall Number: Z-0132-2022 SIGNA Architect Recall Number: Z-0133-2022 SIGNA Pioneer Recall Number: Z-0134-2022 Discovery MR750w 3.0T Recall Number: Z-0135-2022 Discovery MR750 3.0T Recall Number: Z-0136-2022 SIGNA Creator, SIGNA Explorer Recall Number: Z-0137-2022 SIGNA Voyager Recall Number: Z-0138-2022 SIGNA Artist Recall Number:...Read More

September 17, 2021 CMS 617922 Excerpts from a warning letter of interest to software professionals: “The United States Food and Drug Administration (FDA) conducted an inspection of your medical device operations at 200 W. Mercer Street, Suite 500, Seattle, WA 98119 from June 3, 2021 through July 15, 2021. During the inspection, an FDA Investigator...Read More

FDA’s Digital Transformation and the regulation of Medical Device Cybersecurity? I read the recent FDA post that discussed the FDA’s Digital Transformation: “Today, the U.S. Food and Drug Administration announced the reorganization of the agency’s information technology (IT), data management and cybersecurity functions into the new Office of Digital Transformation (ODT).” Then I was reading...Read More

You may be interested in attending the FDA Virtual Public Workshop, “Transparency of Artificial Intelligence/Machine Learning-enabled Medical Devices,” planned for October 14, 2021.   Info on attending:  https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/virtual-public-workshop-transparency-artificial-intelligencemachine-learning-enabled-medical-devices  Read More

The US FDA released the 2022 user fees for certain medical device submissions and establishment registration. On August 2, 2021, the FDA announced the FY2022 user fees in a Federal Register notice titled Medical Device User Fee Rates for Fiscal Year 2022. FY2022 User fees are required for the following types of medical device submissions:...Read More

One of the most important references in creating a software development lifecycle process to assure software quality is the FDA guidance document, “General Principles of Software Validation.”  This guidance document has been around for many years.  The current version, 2.0, was released in 2002.  To many in the industry, this guidance is simply referred to...Read More

The FDA released a guidance document on the non-clinical testing and clinical considerations of ‘Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation’. The document can be downloaded from the FDA website. One point of particular interest comes from the software section, where the FDA states that “We generally consider the software for...Read More

Company: Olympus Corporation of the Americas Date of Enforcement Report: June 30, 2021 Class II PRODUCT Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in urology, lithotripsy, gastroenterological surgery and gynecological...Read More

On June 7th, 2021, the FDA updated their database of recognized consensus standards. This update included two new items related to medical device software. These two items are IEEE standards that are relevant to all medical devices that claim interoperability with other networked entities. They are being recognized based on their scientific and technical merit...Read More

The FDA’s Office of Science and Engineering Laboratories (OSEL) works to promote the innovation and development of new lifesaving medical devices. Their goal is to use the latest science to expedite the development of medical devices. The FDA would like to bring awareness to the 20 research programs that are in place for the advancement...Read More

The FDA is officially modifying medical device classifications for some software functions. On April 19, 2021, the agency published a “final” rule that updates eight classification regulations by amending these regulations to exclude software functions that no longer fall within the device definition under 201(h) of the FD&C Act. With this final rule, FDA is amending the...Read More

(April 6, 2021)— Ginny Kwan Gattinger has joined Crisis Prevention and Recovery LLC (DBA SoftwareCPR®) as a Partner. Ginny is a regulatory affairs professional specializing in software-based products with over 10 years of experience in the regulated industry including medical devices, pharmaceuticals and biotechnology. Ginny has developed regulatory strategies for a variety of SiMD/SaMD and...Read More

On a recent podcast of Quality Injection Podcast EP12, our General Manager Brian Pate spoke with Oded Assouline on the topic of US FDA Design Controls and in particular Design Input.  Some of the questions they explored were Is a concept phase needed for defining the product or device that meets the user needs. Are validation...Read More

Devices that do not meet the criteria for the Breakthrough Devices Program may have a new option under the Safer Technologies Program for Medical Devices (STeP). Read our previous post on the the Breakthrough Devices Program here: FDA Breakthrough Devices Program Draft Guidance. SteP is a voluntary program for certain medical devices that are “reasonably...Read More

Is it possible to view draft revisions of FDA guidance documents when they are a “work in progress,” or are they only become available once published as draft?  This is a frequent question that I have heard. However, the FDA does not typically provide copies or drafts of “works in progress” for those items that...Read More