By

Allison Pate
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...
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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...
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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:...
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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....
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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....
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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...
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Learn about the Canadian regulatory framework from SoftwareCPR® partner, Ginny Kwan Gattinger, who will give a presentation at the RAPS Global Regulatory Strategy Conference in Baltimore, MD on March 7, 2024, at 10:30 am EST. The conference is being held at the Hilton Baltimore near the BWI Airport. Ginny will co-present with our affiliate, Karen...
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62304 Public Training Course Course Dates:  June 5-7, 2024 COST: 3 Full Days for $2,900.00 (50% refundable through January 31, 2024. Fully transferable at any time.) Limited number of Early Bird discount coupons (worth $895)  available on a first come-first serve basis.  Use coupon code: “30per” (thats three-zero-letter p-letter e-letter r) Early bird discount available through...
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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,...
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Oriented for Central European Time! 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: February 12-15, 2024 (16 hours of training) HOURS:  1300-1700 CET each day TRAINING LOCATION: Virtual – live online COST: 4 half days for...
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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...
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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....
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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....
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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:...
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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...
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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...
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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...
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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,...
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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...
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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....
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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...
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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...
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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:...
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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...
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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...
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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...
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Company: Impedimed Limited Date of Enforcement Report: 10/24/2023 Class II PRODUCT SOZO Bilateral Arm L-Dex Software Recall Number: Z-0155-2024 REASON: Bilateral L-Dex assessment software does not have the same level of sensitivity to help detect early signs of lymphedema as the unilateral arm L-Dex assessment, which could result in under-recognition of early lymphedema, which could...
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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...
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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...
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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...
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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...
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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,...
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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...
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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...
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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...
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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...
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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...
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Company: Baxter Healthcare Corp. Date of Enforcement Report: 09/28/2023 Class II PRODUCT Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) v6.1.x, b) v6.2.x, c) v7.0.x. Recall Number: Z-2647-2023 REASON: Epiphany, now a Baxter Healthcare company, is issuing an Urgent Medical Device Correction for the Cardio Server E3 ECG Management System...
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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...
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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,...
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AbioMed was issued a warning letter from the FDA for reason “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, 21 U.S.C. § 360e(a), or...
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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...
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Lex Inc. was issued a warning letter from the FDA for reason “of vulnerabilities in hardware and software, encompassing both networked and non-networked systems (e.g., programmable logic controller (PLC)).” More specifically, “a list of all software configurations (both equipment software and laboratory information management system (LIMS)) and versions, details of all user privileges, and oversight...
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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:...
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Company: Stryker Corporation Date of Enforcement Report: 08/25/2023 Class II PRODUCT SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting, displaying and recording the number of RFID-tagged absorbent articles used during surgical procedures Product Code: 0694-002-090. Recall Number: Z-2463-2023 REASON: Potential for current software to miscount when scanning in multiple...
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Company: Medtronic Neuromodulation Date of Enforcement Report: 07/21/2023 Class II PRODUCT A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application.. Recall Number: Z-2226-2023 REASON: When an update to the A710 Clinician Programmer software application for the Intellis Neurostimulation System was released, the corresponding version of the A901 Communication Manager software application...
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Company: Hamilton Medical, Inc. Date of Enforcement Report: 07/21/2023 Class I PRODUCT HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates. Recall Number: Z-2139-2023 REASON: Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop...
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Company: Digisonics, Inc Date of Enforcement Report: 07/20/2023 Class II PRODUCT Digisonics OBView Versions 4.8.2 SP6 – 4.8.3, Ultrasound reporting software Recall Number: Z-2214-2023 REASON: Software issue RECALLING FIRM/MANUFACTURER: Digisonics, Inc VOLUME OF PRODUCT IN COMMERCE: 32 units DISTRIBUTION: US Distribution: AK, NH, WY, TX, NE, CA, MD, TX, OR IA, IL, MO, OR, NY,...
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Company: Beckman Coulter Biomedical GmbH Date of Enforcement Report: 07/14/2023 Class II PRODUCT Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly Recall Number: Z-2144-2023 REASON: A software defect in the DxA Automation System may cause tests to be run on patient samples in tube types not compatible with the...
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Company: Baxter Healthcare Corporation Date of Enforcement Report: 07/13/2023 Class I PRODUCT SIGMA Spectrum Infusion Pump, Product Code 35700BAX2 Recall Number: Z-2103-2023 REASON: A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps due to an increase in reported...
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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:  June 5-7, 2024
Boston, MA

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

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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: February 12-15, 2024

Virtual via Zoom

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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

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