Category

News
Company: Outset Medical, Inc. Date of Enforcement Report: 4/07/2023 Class II PRODUCT Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system (Hemodialysis System or System), intended for acute, home and chronic dialysis therapy with or without ultrafiltration, in an acute or chronic care facility. Recall Number: Z-1351-2023 REASON: An...
Read More
Company: Shanghai United Imaging Healthcare Co., Ltd Date of Enforcement Report: 4/7/2023 Class II PRODUCT Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057 Recall Number: Z-1353-2023 REASON: Due to a software issue where the process of patient scanning, the scatter correction may...
Read More
FDA Draft Submission Guidance AI/ML For Use of AI/Machine Learning-Enabled Device Software Functions Almost every day there is another news story about something involving “artificial intelligence.” So it seems timely that the FDA has just released a draft guidance for Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device...
Read More
(Denis Pasero. Med-Tech News. 3-10-23) Microbatteries in implantable devices are allowing earlier detection along with closer and more regular observation of the patient. A major benefit would be the real-time monitoring of the patient in areas not previously possible due to size, comfort levels, and the complexity of surgery. Much work is still to be...
Read More
Company: CareFusion 303, Inc. Date of Enforcement Report: 3/01/2023 Class II PRODUCT Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x.x.255 Recall Number: Z-1192-2023 REASON: Infusion pump PCs with specific software/network cards/IP addresses can have network/wireless connection failure. Could cause inability to receive new...
Read More
Company: Stryker Corporation Date of Enforcement Report: 2/27/2023 Class II PRODUCT Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Catalog Number: FG 12010. Intended adjunct in the estimation of blood loss. RECALL NUMBER: Z-1184-2023 REASON: Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output...
Read More
Company: Getinge Usa Sales Inc Date of Enforcement Report: 1/26/2023 Class I PRODUCT Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400 Programmable Diagnostic Computer Recall Number: Z-0959-2023 REASON Due to a software bug, under certain conditions, pressure cannot be built up resulting in no...
Read More
Company: Align Technology Inc. Date of Enforcement Report: 1/26/2023 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
(Jim Lynch. Science Daily. University of Michigan. 01-02-2023) New 3D imaging capturing sound waves by X-rays provides the ability to map radiation doses. Doctors are now equipped with real-time data to guide treatments. Prior to this break through, medical professionals were left in the dark as to how much radiation was hitting their target area....
Read More
Company: Agfa Healthcare NV Date of Enforcement Report: 1/20/2023 Class II PRODUCT Agfa HealthCare Enterprise Imaging XERO Viewer Recall Number: Z-0775-2023 REASON There is a software defect that can cause issues with images. RECALLING FIRM/MANUFACTURER Agfa Healthcare NV VOLUME OF PRODUCT IN COMMERCE 110 units DISTRIBUTION Distribution throughout US OUS distribution to Australia, Belgium, Brazil,...
Read More
Company: Medtronic Neuromodulation Date of Enforcement Report: 01/06/2023 Class II PRODUCT Devices Recall Number: Z-0911-2023 REASON Software anomalies, CP App messages: “Too Many Device Found”, “Unexpected Device Error Code 1502”, and “System Update Needed, Service Code 303” RECALLING FIRM/MANUFACTURER Medtronic Neuromodulation VOLUME OF PRODUCT IN COMMERCE 440 units DISTRIBUTION Worldwide distribution
Read More
(Ann R. Thryft. 11-16-22. Mddionline.com) A team made up of Sensoria Health, Foot Defender, and former Nike shoe designers came together to create a cloud-based patient monitoring boot for Diabetes patients. On the extreme, but very realistic side, this technology could help save patients from requiring an amputation if used correctly after ulcer surgery. The...
Read More
Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report: 12/31/2022 Class II PRODUCT Programmable Diagnostic Computer Recall Number: Z-0775-2023 REASON The firm will be performing a software update to address a software error which affects the listed products. This correction addresses four potential software issues: 1) “PASSWORD STORE CORRUPTED” error message during system boot;...
Read More
(Med-TechNews, December 12, 2022). Sir Nicholas Wright and Digistain in the UK has created a new tool to aid the early detection of breast cancer. Based on clinical trials, this new development is helping those eligible successfully avoid chemotherapy through earlier and more personalized test results. This allows patients more time to make decisions, less...
Read More
Company: Fresenius Medical Care Holdings, Inc. Date of Enforcement Report:12/20/202 Class II PRODUCT 2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models: (1) 190713 2008T HEMODIALYSIS SYS., with CDX; (2) 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG W/CDX ; (3) 191124 2008T HD SYS. CDX BLUESTAR; (4) 191126...
Read More
RightEye, LLC was issued a Warning Letter from the FDA due to “the RightEye Vision System was cleared under K181771 with the following indications: “recording, viewing, and analyzing eye movements in support of identifying visual tracking impairment in human subjects.” However, your firm’s promotion of the device provides evidence that the device is intended to...
Read More
(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...
Read More
This Playbook was prepared by The MITRE Corporation and the Medical Device Innovation Consortium using funds from the U.S. Food and Drug Administration in November 2021.  Download playbook here:  Playbook-for-Threat-Modeling-Medical-Devices-2021 The playbook is not prescriptive in that it does not describe one approach to be used when threat modeling medical devices. It is intended to...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
(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....
Read More
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...
Read More
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...
Read More
(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...
Read More
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...
Read More
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...
Read More
(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.  
Read More
(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...
Read More
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...
Read More
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....
Read More
(October 6, 2022. Health IT Security) The FDA has issued a user fee re-authorization bill but due to fast approaching deadlines among other constricting legislative factors, the House bill has left out medical device security leaving some experts weary of it’s consequences. https://healthitsecurity.com/features/experts-weigh-in-on-medical-device-security-exit-from-fda-user-fee-bill
Read More
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....
Read More
(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...
Read More
MicroVention located in Costa Rica was issued a warning letter from the FDA for reason “that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of...
Read More
(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...
Read More
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....
Read More
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
1 2 3 4 5 92

SoftwareCPR Training Courses:

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future.  Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply.  Special deep discount pricing available to FDA attendees and other regulators.

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

Instructor: Brian Pate

Next public offering:  TBD

Email training@softwarecpr.com to request a special pre-registration discount.  Limited number of pre-registration coupons.

Registration Link:

TBD

 


 

Being Agile & Yet Compliant (Public or Private)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for scheduling!

  • Agile principles that align well with medical
  • Backlog management
  • Agile risk management
  • Incremental and iterative software development lifecycle management
  •  Frequent release management
  • And more!

2-days onsite (4 days virtual) with group exercises, quizzes, examples, Q&A.

Instructors: Mike Russell, Ron Baerg

Next public offering: March 7 & 28, 2024

Virtual via Zoom

Registration Link:

Register Now

 


 

Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

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

Instructor: Dr Peter Rech, 2nd instructor (optional)

Next public offering:  TBD

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.