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(November 8, 2022. Nick Paul Taylor. MedTech Dive) H2o Therapeutics is the company behind the app, Parky, which promises to track Parkinson’s symptoms using an Apple watch. Patients are able to take advantage of Apple’s pre-existing movement disorder API features in their wearables. This can provide valuable and reliable insight to clinicians between visits through...
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Crisis Prevention and Recovery, LLC / SoftwareCPR, Tampa, FL USA – (November 22, 2022) “We are pleased to announce that our Partner and General Manager, Brian Pate, has been selected  for membership on the UL 1998 Standards Technical Panel for Software (STP), with oversight of UL 1998 standard, Software in Programmable Components.  Brian will provide stakeholder input to...
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Company: Abbott Molecular, Inc. Date of Enforcement Report: 11/18/2022 Class II PRODUCT Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use Recall Number: Z-0268-2023 REASON Abbott has identified potential performance issues for the Alinity m System software version 1.6.5: 1) In a unique scenario, the waste chute flapper was found to not open when...
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Registration now for our next “Being Agile and Yet Compliant” Training Course.  Our fall offering is coming up.  Conveniently scheduled to work across many timezones! COURSE DATES: December 12-15, 2022 (16 hours of training) HOURS:  11 am until 3 pm EDT each day TRAINING LOCATION: Virtual – live online COST: 4 half days for $1,920...
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Crisis Prevention and Recovery, LLC / SoftwareCPR, Tampa, FL USA – (November 15, 2022) “We are pleased to announce that our partner, Dr Peter Rech, has been reappointed to serve the next 3 years as convener for IEC technical committee 62/SC 62D/MT23 Infusion Pumps.  In this role, Dr Rech will be responsible for organizing and administering...
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(November 8, 2022. Nick Paul Taylor. MedTech Dive)  Could a “biomechanical energy harvester turn the movement of the chest wall during inhalation and exhalation into power for a DBS device”? Nick Paul Taylor discusses this as a very real possibility. This would reduce the need to complete a surgery every few years for battery changes....
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ISO 14971:2019 Medical Device Risk Management, A Software Organization’s Perspective Public Training Course DATES:  Jan 9-11, 2023 Includes “how to” for application of IEC 62304 for software risk management! COST: 3 Full Days for $2,995 DISCOUNTS: 3 or more students from same company: 10% discount (off full registration) November 2022 Early Registration:  $2,395 Register at...
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Company:Boston Scientific Corporation Date of Enforcement Report: 10/31/2022 Class II PRODUCT ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000 Recall Number: Z-0151-2023 REASON There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc VOLUME OF PRODUCT IN COMMERCE 7 devices...
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(October 23, 2022. MedPage Today. Dane Brodke, MD, MPH) Some are suggesting hospital fines for the rising EMR burden might be a small step in the right direction to alleviate the undue time and stress put on healthcare workers. Though those on the front lines understand the only real answer to the burnout crisis is...
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FDA releases Guidance on AI requests.  To aid manufacturers and reviewers, this guidance emphasizes the “Least Burdensome Provisions” when responding to deficiencies in a regulatory submission.  Download the final guidance: 2022-guidance-responding-deficencies-least-burdensome As stated by FDA, this guidance is “intended to help FDA staff develop, and industry respond to, a request for additional information needed to make a...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 10/21/2022 Class II PRODUCT ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000 Recall Number: Z-0119-2023 REASON Siemens has become aware of three potential software issues with ARTIS pheno systems with software version VE10B. This may lead to a hazardous situation for patients if treatment...
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(October 18, 2022. Janette Wider. Healthcare Innovation Group) One main challenge in keeping medical devices secure is the management of hardware design alongside the underlying software. Though the degree of impact on a patient will vary based on the device, these threats do have the potential for life-threatening implications.  
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(October 11, 2022. Elise Reuter. MedTechDive) The FDA issued updated recommendations for Industry and FDA staff. This guide includes CDS software functions to better understand what meets the definition of device. This welcomed clarity brings to light predictive tools that are now meet the criteria for device. Now, experts are weighing in on what predictive...
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See more discussion on Risk Management Training between our General Manager, Brian Pate, and our Partner, Dr. Peter Rech, regarding changes to ISO 14971 as they prepare for our January 2023 public training course on the application of ISO 14971 and IEC 62304 to system risk analysis and software risk analysis.  Our 3-day course will...
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Since October is Cybersecurity Awareness Month, the US FDA released a new video to provide ideas and approaches for Healthcare Professionals (HCP) discuss and explain to patients, the concepts and methods for cybersecurity with regard to  interconnected medical devices.   The video titled, “xx,” is designed to promote, and perhaps facilitate, communication  between HCPs and patients....
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Company: Fresenius Kabi USA, LLC Date of Enforcement Report: 10/6/2022 Class I PRODUCT Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0 Recall Number: Z-0002-2023 REASON The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification....
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(September 29, 2022. Jim Hammerand) FDA and VA Ventures Innovation Institute will begin a five year partnership beginning with a focal point on interoperable systems before applying their combined strength to telehealth and artificial intelligence among others. The two agencies aim to provide the most advanced health tech faster than ever before. FDA and VA...
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(Tampa, FL, September 28, 2022) – Crisis Prevention and Recovery, LLC is taking proactive steps to minimize impact to our clients from the landfall of Hurricane Ian in Southwest Florida.  With our corporate office in Tampa, Florida, it is likely that there could be loss of electrical power and/or internet in the next 24 to 72...
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Company: Micro-X Ltd. Date of Enforcement Report: 9/23/2022 ClassII PRODUCT MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19 Recall Number: Z-1786-2022 REASON Software calibration error with product equip with a Dose Area Product (DAP) meter. This results in the product displaying the incorrect DAP meter values which may impede radiation exposure management decisions RECALLING FIRM/MANUFACTURER Micro-X Ltd....
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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Recently, a new cybersecurity standard, IEC 81001-5-1:2021, Health software and health IT systems safety, effectiveness and security – Part 5-1: Security – Activities in the product life cycle, was released.  As the name implies, this standard addresses the overall software development lifecycle (SDLC) with regard to cybersecurity activities.  For medical device manufacturers, this is very...
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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...
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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...
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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...
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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...
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FDA is requesting input on patient safety, including best practices to promote patient safety, education, and competency, associated with Non-Medical Device Software – software excluded from the medical device definition by the 21st Century Cures Act.  Software professionals should take this opportunity to explain the risks associated with non-medical device software interacting with medical device...
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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:...
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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...
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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...
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Company: Haemonetics Corporation Date of Enforcement Report: 6/28/2022 Class II PRODUCT Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TEG Platelet Mapping Assay – PlateletMapping ADP & AA (07-014), PlateletMapping ADP (07-015), PlateletMapping AA (07-016). Issue occurs when Platelet Mapping Assay results from a TEG 5000 analyzer are viewed using...
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The Markup, a nonprofit newsroom that investigates how powerful institutions are using technology to change our society, reports that Facebook has been collecting patients’ sensitive health information—including details about their medical conditions, prescriptions, and doctor’s appointments—and sending it to Facebook.  They found that 33 of Newsweek’s top 100 hospitals in America contained a tracker, called the...
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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...
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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...
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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...
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Company: bioMerieux, Inc. Date of Enforcement Report: 5/25/2022 Class II PRODUCT VITEK 2 automated system. Recall Number: V-0141-2022 REASON Software issue where results sent to the LIS via HL7 format for antibiotic screen tests and synergy tests to not include the user-corrected or AES-corrected interpretation. This can potentially lead to incorrect final screen/synergy test results...
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Company: Daavlin Distributing Company Date of Enforcement Report: 5/18/2022 Class II PRODUCT 1 Series CX phototherapy units equipped with Daavlin’s ClearLink Control System software versions v3.03h and 3.04v. Models: 1 Ser CX 305-4 120-240V 50/60Hz, item # 06OS0004CX6 1 Ser CX 311-4 120-240V 50/60Hz CE, item # 807OS0004CX5 1 Ser CX 311-4 120-240V 50/60Hz, item...
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Company: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Date of Enforcement Report: 5/11/2022 Class II PRODUCT Azurion systems with software release R1.x Recall Number: Z-0886-2022 REASON In the Azurion system, the user can add a new study to a patient by selecting the option Add Study . The Add Study dialogue box is then displayed where the...
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Company: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Date of Enforcement Report: 5/11/2022 Class II PRODUCT Azurion systems with software release R1.x Recall Number: Z-0886-2022 REASON In the Azurion system, the user can add a new study to a patient by selecting the option Add Study . The Add Study dialogue box is then displayed where the...
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Company: DePuy Orthopaedics, Inc. Date of Enforcement Report: 5/11/2022 Class II PRODUCT VELYS Robotic-Assisted Solution Base Product No.: 451570100 Recall Number: Z-1029-2022 REASON System software v1.5.1 has a system software issue related to the Daylight Savings Time (DST) change that can cause a system error, requiring the user to restart the system and potentially cause...
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Upcoming SoftwareCPR Training Courses:

Public Course – Jan 9-11, 2023 – Risk Management (in-person)

Our newly updated ISO 14971:2019 Medical Device Risk Management, A Software Organization’s Perspective public training course is now open for registration!

Where:  Tampa, Florida

  • Coverage of ISO 14971:2019, IEC 62304; amd1, and IEC/TR 80002-1.
  • System level hazards analysis – mapping to software, cybersecurity, and usability
  • Why FMEA is incomplete for medical device risk management.
  • How to perform software hazards analysis.
  • And more!

3-days onsite with group exercises, quizzes, examples, Q&A.

Instructors: Dr. Peter Rech, Brian Pate

Discount Registration through October 31, 2022.  Reserve your spot!

Register here: https://events.eventzilla.net/e/2023-softwarecpr-public-training-course–iso-14971-medical-device-risk-management-a-software-organizations-perspective-2138576610

 

Public Course – Dec 12-15, 2022 – Being Agile & Yet Compliant (virtual)

COST: 4 half days for $1,920 per person

HOURS: 11 am until 3 pm EDT each day

TRAINING LOCATION: Virtual – live online

Register here:

https://events.eventzilla.net/e/december-2022-softwarecpr-agile-and-compliant-training-course-2138573767

 

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