Tag

fda
Company: Fresenius Kabi USA, LLC Date of Enforcement Report: 3/11/2024 Class II PRODUCT LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004 Recall Number: Z-1282-2024 REASON: Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop) Alarm when an administration set is loaded with an upstream occlusion present, resulting in a non-recoverable...
Read More
Today, FDA published a guidance paper for the use of augmented reality (AR) & virtual reality in medical devices. The information from that paper is provide below. Medical Extended Reality (XR), which includes Augmented Reality (AR) and Virtual Reality (VR), has the potential to deliver new types of treatments and diagnostics, transforming how and where...
Read More
I (Mike Russell) attended the neXus conference on medical device standards this year. Below are some observations and suggested takeaways from the talks I heard and the panel I was on. Remember, these are just selected highlights, not everything said 🙂 Session: Reducing Submission Rejections and Recalls with Software Standards This year’s conference added a third...
Read More
Company: Ortho-Clinical Diagnostics, Inc. Date of Enforcement Report: 3/1/2024 Class II PRODUCT VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished) Recall Number: Z-1224-2024 REASON: A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause...
Read More
SoftwareCPR® partner Mike Russell is attending the AAMI/FDA neXus medical device standards conference this week in Washington D.C., and chairing a panel. This year’s conference has added a third standards success track: application. Accordingly, Mike is chairing a panel session today on “Reducing Submission Rejections and Recalls with Software Standards.” In addition to his experience...
Read More
Company: PTW-FREIBURG Date of Enforcement Report: 2/22/2024 Class II PRODUCT Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology. Recall Number: Z-1181-2024 REASON: Software: If the user excludes voxels from the Gamma calculation that are below a dose...
Read More
One of the cornerstones of a quality management system is the integrity of the quality system records. It should go without saying how critical it is for these records to be truthful, accurate, and genuine. Fraudulent data can lead to an unsafe medical device, or a medical device that does not fully achieve its intended...
Read More
Company: Baxter Healthcare Co. Date of Enforcement Report: 02/16/2024 Class I PRODUCT ExactaMix Pro 1200 and the Pro 240 with software 2.0.8 and 2.1.8 Recall Number: Z-1002-2024 REASON: Baxter Healthcare is recalling the ExactaMix Pro 1200 and the Pro 2400 because of a software error that can cause more ingredients than needed to be added...
Read More
Company: Baxter Healthcare Corporation Date of Enforcement Report: 2/16/2024 Class I PRODUCT Baxter Exactamix Pro 1200, REF EXM12DY Recall Number: Z-1001-2024 REASON: An error was identified in software versions 2.0.8 and 2.1.8 while using the “Use Some Overfill” feature which may lead to over-delivery of an ingredient. This issue can result in redundant ingredient delivery...
Read More
Company: Smiths Medical ASD, Inc. Date of Enforcement Report: 2/14/2024 Class I PRODUCT Smiths Medical, Medfusion Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates. Recall Number: Z-2107-2012 REASON: Smiths...
Read More
Company: PHILIPS MEDICAL SYSTEMS Date of Enforcement Report: 2/8/2024 Class II PRODUCT Spectral CT on Rails: Software Version 5.1.0.X, model 728334 Recall Number: Z-1054-2024 REASON: A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment. RECALLING FIRM/MANUFACTURER: PHILIPS MEDICAL SYSTEMS VOLUME OF PRODUCT IN COMMERCE: US:...
Read More
Company: Thoratec Corp. Date of Enforcement Report: 2/2/2024 Class I PRODUCT 1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Communication System, HMT1150 The HeartMate Touch Application is loaded onto a tablet and will provide a user interface with state-of-the-art hardware/software platforms for supporting LVAD patients....
Read More
Company: Smiths Medical ASD Inc. Date of Enforcement Report: 2/1/2014 Class I PRODUCT Smith’s Medical Medfusion Model 3500 Syringe pump Recall Number: Z-0863-2024 REASON: Medfusion syringe pumps, with software versions before v6.0.0, may have the following issues:1. Delivery During Motor Not Running High Priority Alarm, 2. Infusion Restarted with Incorrect Parameters, 3. Screen Lock, 4....
Read More
Company: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Date of Enforcement Report: 1/30/2024 Class II PRODUCT Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12) Recall Number: Z-0860-2024 REASON: Loss of connectivity between the FlexArm and the Table due to a software issue. RECALLING FIRM/MANUFACTURER: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. VOLUME...
Read More
Deymond Diagnostics s.r.o. was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: The “inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for,...
Read More
iRythm Technologies, Inc. was issued a warning letter from the FDA. SoftwareCPR comments: This Warning Letter demonstrates the need for: Quality systems to stay compliant (CAPA and complaints!) Regulatory oversight to engineering and marketing activities Really communicating product behavior in the IFU!!” Excerpts from a warning letter of interest to software professionals: “As stated in...
Read More
Company: Philips Healthcare (Suzhou) Co., Ltd. Date of Enforcement Report: 1/5/2024 Class II PRODUCT Incisive CT, model 728143 & 728144 running Software Version 5.0.0. Recall Number: Z-0640-2024 REASON: Multiple software issues which have the potential to lead to misdiagnosis due to image artifacts or incorrect image orientation labels, or the need for a CT rescan....
Read More
Company: Boston Scientific Corporation Date of Enforcement Report: 1/5/2024 Class II PRODUCT Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Application Software used for the following pacemaker products: ALTRUA 20, ALTRUA 40, ALTRUA 60, INSIGNIA I Entra, INSIGNIA I Plus, INSIGNIA I Ultra, NEXUS I Entra, and NEXUS I Plus....
Read More
Company: Covidien Date of Enforcement Report: 1/3/2023 Class II PRODUCT Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD Recall Number: Z-0631-2024 REASON: Due to software issue, New systems may exhibit an error which may prohibit use of new systems resulting in system being inoperable. RECALLING FIRM/MANUFACTURER: Covidien VOLUME OF PRODUCT IN COMMERCE:...
Read More
Company: Abbott Date of Enforcement Report: 1/3/2024 Class I PRODUCT HeartMate Touch Communication System (version 1.0.32) Recall Number: Z-0842-2024 REASON: Abbott is recalling their HeartMate Touch System (version 1.0.32) for risk of unexpected pump stop or start. Issues may occur if the HeartMate Touch System is disconnected from a patient’s HeartMate Controller while a “pump...
Read More
Company: Abbott Laboratories Date of Enforcement Report: 12/22/2023 Class II PRODUCT Alinity ci-series System Control Module, REF: 03R70-01 Recall Number: There are potential performance issues found in the Alinity ci-series System software versions 3.4.0 and lower, including: 1) SCC Reagent load error during daily maintenance; 2) Sample Laboratory Report error; 3) Customer requests mechanism to...
Read More
Company: Abbott Laboratories Date of Enforcement Report: 12/22/2023 Class II PRODUCT Alinity ci-series System Control Module, REF: 03R70-01 Recall Number: Z-0613-2024 REASON: There are potential performance issues found in the Alinity ci-series System software versions 3.4.0 and lower, including: 1) SCC Reagent load error during daily maintenance; 2) Sample Laboratory Report error; 3) Customer requests...
Read More
Company: Siemens Healthcare Diagnostics Inc Date of Enforcement Report: 12/20/2023 Class II PRODUCT epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX), 11413518 (ROW), 11413498 (JP), 11413583 (CN, KR), 11413879 (IN) with software versions from 4.9.4 to the current version 4.11.11 Recall Number: Z-0601-2024 REASON: Siemens Healthcare...
Read More
Company: Philips North America Llc Date of Enforcement Report: 12/18/2023 Class II PRODUCT The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment supports,...
Read More
Company: Ortho-Clinical Diagnostics, Inc. Date of Enforcement Report: 12/13/2023 Class II PRODUCT VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0 Recall Number: Z-0543-2024 REASON: During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface...
Read More
Company: Medtronic Inc. Date of Enforcement Report: 12/09/2023 Class II PRODUCT Medtronic SynchroMed, Model A10 Recall Number: Z-0522-2024 REASON: The previous software application version (1.1.300) is missing a decimal separator (a comma) for parameter range guidance values displayed on some of the programming screens: Catheter, Reservoir, Infusion, Bolus, myPTM, and Alarm. RECALLING FIRM/MANUFACTURER: Medtronic Inc....
Read More
Company: Bebig Isotopentechnik Gmbh Date of Enforcement Report: 12/08/2023 Class II PRODUCT SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System Recall Number: Z-0517-2024 REASON: Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements. RECALLING FIRM/MANUFACTURER: Bebig Isotopentechnik Gmbh VOLUME OF PRODUCT IN COMMERCE: 2 software licenses in US, 255...
Read More
Fresenius Medical Care AG & Co. KGaA was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: “This inspection revealed that the above devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the...
Read More
Company: AURIS HEALTH INC Date of Enforcement Report: 12/01/2023 Class II PRODUCT Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w Recall Number: Z-0448-2024 REASON: There is the potential that software issues may result in flipped image of the virtual Bronchoscope view. RECALLING FIRM/MANUFACTURER: AURIS HEALTH INC. VOLUME OF PRODUCT IN COMMERCE: 110 units In total DISTRIBUTION:...
Read More
Cybersecurity for legacy medical devices plays a crucial role in healthcare but to remove these devices may pose a greater risk to patient safety, clinical operations, and financial stability than to leave them in service. The challenging task of “securing” these legacy devices is paramount. It must be recognized that overall management of the risk...
Read More
Company: Philips North America Date of Enforcement Report: 11/15/2023 Class II PRODUCT Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 Recall Number: Z-0306-2024 REASON: When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the operator may experience a software crash. This would result in the system needing to be...
Read More
Company: Medtronic Navigation, Inc. Date of Enforcement Report: 11/09/2023 Class I PRODUCT StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. The StealthStation FlexENT System, with StealthStation ENT software, is intended as...
Read More
The U.S. Food and Drug Administration (FDA) announced today that AAMI SW96 Receives FDA Consensus Standard status.  Medical device manufacturers are now expected to conform to the requirements of this standard as applicable, or have processes that show address the requirements of the standard. The broad outline of AAMI SW96 is: General requirements for security...
Read More
Company: Acclarent, Inc. Date of Enforcement Report: 10/20/2023 Class II PRODUCT TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005 Recall Number: Z-0127-2024 REASON: When using affected curette and software, there is a discrepancy between the actual curette tip location and the location displayed on navigation systems intended...
Read More
Wavi Co. was issued a warning letter from the FDA for reason of “failure to perform validation of device software as required by 21 CFR 820.30(g).” More specifically, “Your firm distributed at least 90 WAVi Complete Systems consisting of WAVi Headsets, WAVi eSoc single use electrodes, electrode contacts, Electronic Processing Units [EPU], ear clips, Heart...
Read More
Company: EITAN MEDICAL LTD Date of Enforcement Report: 10/19/2023 Class I PRODUCT Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001) Recall Number: Z-0094-2024 REASON: Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism. RECALLING FIRM/MANUFACTURER: EITAN MEDICAL LTD VOLUME...
Read More
Company: OLEA MEDICAL Date of Enforcement Report: 10/18/2023 Class II PRODUCT Functional MR V1.0 Recall Number: Z-0122-2024 REASON: When exporting regions of interest in DICOM SEGMENTATION format, when simultaneously exporting multiple volumes of interest, a functional magnetic resonance software bug may cause file contents and associated series descriptions to not match, which could lead to...
Read More
FDA issues a warning letter for Abiomed Inc. for the reason of “Our inspection also revealed the Impella Connect System device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act,...
Read More
Company: Blue Belt Technologies, Inc Date of Enforcement Report: 10/05/2023 Class II PRODUCT Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299 Recall Number: Z-0041-2024 REASON: CORI software was missing a planning stage that appears in cases of significant knee deformation (outside of the range of 3 degrees...
Read More
Company: Philips North America Llc Date of Enforcement Report: 09/29/2023 Class II PRODUCT EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380 Recall Number: Z-2654-2023 REASON: A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated. RECALLING...
Read More
Company: Philips Healthcare Date of Enforcement Report: 09/29/2023 Class II PRODUCT Incisive CT, software version 5.0 Recall Number: Z-2520-2023 REASON: Philips has identified three software issues with compliance concerns to Subchapter J: Issue 1: Coronary Computed Tomography Angiography (CTA) scan may not be triggered at the optimal time. Issue 2: Use of aborted surview for...
Read More
Company: Medtronic Neuromodulation Date of Enforcement Report: 09/29/2023 Class II PRODUCT Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators. Recall Number: Z-2657-2023 REASON: The original version of the A71100 Restore Clinician Programmer Application has been identified to have a compatibility issue with some legacy clinician programmer software resulting in the...
Read More
Company: CareFusion 303, Inc. Date of Enforcement Report: 09/28/2023 Class II PRODUCT BD Pyxis MedBank MedPass Software, REF: 139088-01 Recall Number: Z-2646-2023 REASON: After dispensing a timed dose medication for a patient, the automated dispensing cabinet software may continue to show the already dispensed medication dose is still available for dispense, which could lead to...
Read More
Company: Exocad GmbH Date of Enforcement Report:9/25/2023 Class II PRODUCT exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-operative planning of dental implants using the visualization of the implant placement within images of the patents anatomy. Recall Number: Z-2633-2023 REASON: A software library filtering error has been discovered which occurs when...
Read More
Sonesta Medical AB was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: “This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for,...
Read More
By Ron Baerg and Mike Russell “You can pay me now, or you can pay me later” was the punch line of a memorable TV commercial by the FRAM® company about their oil filters around 50 years ago. The “me”: a car mechanic. Their point: paying (a little) now to replace your oil filter regularly...
Read More
What does the US FDA expect in a premarket submission for description of the software design?  In the recent June 2023 Guidance for Industry and Food and Drug Administration Staff titled, “Content of Premarket Submissions for Device Software Functions,” the FDA gives the following guidance. For lower risk devices, the manufacturer is not required to...
Read More
Company: Diversatek Healthcare Date of Enforcement Report: 09/07/2023 Class III PRODUCT ZVU Functional GI Software, REF: ZVU-3 Recall Number: Z-2521-2023 REASON: GI software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0. RECALLING FIRM/MANUFACTURER: Diversatek Healthcare VOLUME OF PRODUCT IN COMMERCE: 20 DISTRIBUTION: Worldwide – US Nationwide distribution in the states...
Read More
Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report: 08/25/2023 Class II PRODUCT RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care. Model Numbers: 5.0.0, 5.0.1, 5.1.1,5.1.2, 5.1.3, 6.0.0 Recall Number: Z-2464-2023 REASON:...
Read More
1 2 3 15

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.