By

Jordan Pate
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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Company: Becton Dickinson & Co. Date of Enforcement Report: 5/11/2022 Class II PRODUCT BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10 Recall Number: Z-1018-2022 REASON When updating BD Kiestra customers to BD Synapsys version 4.10, the custom antibiotic codes set by the customer are overwritten with the BD default antibiotic codes. RECALLING...
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Company: Medtronic Neuromodulation Date of Enforcement Report: 5/4/2022 Class II PRODUCT MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Model Numbers: 1) TH90Q01, 2) TH90QFA, 3) TH90PFA, 4) TH90GFA, 5) TG90G01; b) InterStim X Clinician Therapy Application Software, Model Number A51300; and c) InterStim x “My Therapy” Patient...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 4/27/2022 Class II PRODUCT SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 4/27/2022 Class II PRODUCT Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327600 Recall Number: Z-0985-2022 REASON Five potential software issues affecting Artis pheno and Artis icono systems...
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Company: Medtronic Xomed, Inc. Date of Enforcement Report: 4/27/2022 Class II PRODUCT Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number EC300RF; c) MASTER CONSOLE EC300 LEGEND EHS, Product Number EC300 Recall Number: Z-0961-2022 REASON As a result of Medtronic’s integrated power console...
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Company: St. Jude Medical, Cardiac Rhythm Management Division Date of Enforcement Report: 4/27/2022 Class II PRODUCT Merlin PCS 3650 programmer Model 3330 software Recall Number: Z-0964-2022 REASON Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchronization therapy defibrillator devices, the...
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Company: SIGHT DIAGNOSTICS LTD Date of Enforcement Report: 4/27/2022 Class II PRODUCT The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image processing to identify and quantify blood components (e.g., red blood cells) and their characteristics (e.g., cell volume) in an automated fashion. Using dedicated...
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Company: Varian Medical Systems Imaging Laboratory GmbH Date of Enforcement Report: 4/20/2022 Class II PRODUCT ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1 Recall Number: Z-0942-2022 REASON Software issue for treatment plan and image management application may result in mismatch values which could result in treatment in the wrong location. RECALLING...
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Company: Remote Diagnostic Technologies Ltd. Date of Enforcement Report: 4/13/2022 Class II PRODUCT Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693 Recall Number: Z-0861-2022 REASON Distribution of Defibrillators that are not approved or cleared for distribution US Market. RECALLING FIRM/MANUFACTURER Remote Diagnostic Technologies Ltd. on 1/28/2022. Voluntary: Firm initiated VOLUME...
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Company: Diagnos Inc. Date of Enforcement Report: 4/6/2022 Class II PRODUCT CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179 Recall Number: Z-0826-2022 REASON Retinal analysis system software has some features, based on artificial intelligence, that potentially lack appropriate market approval, so it is recommended to use a specific prior software version. RECALLING FIRM/MANUFACTURER Diagnos Inc....
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Company: InfuTronix LLC Date of Enforcement Report: 4/6/2022 Class II PRODUCT Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1076-DUKE-HSP and IT1077-DUKE-HSP Recall Number: Z-0832-2022 REASON An unreleased Version 4 Protocol Library was installed on Nimbus PainPro (H) infusion pumps in error that may impact patient safety...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 4/6/2022 Class II PRODUCT Ysio system with VC10 software version, Model Number 10281013. Radiographic system Recall Number: Z-0841-2022 REASON Siemens Healthineers has identified a software error in previous software version VB10 for the Ysio fully automated system. The unit may process incorrect internal values for...
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New Date! COURSE DATES: May 9 – 12, 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 per person Registration Link:  https://events.eventzilla.net/e/2022-softwarecpr-agile-and-compliant-training-course-2138816565 Only a limited number of discounted seats are available.  For more information on the course, use...
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Company: Philips Healthcare Date of Enforcement Report: 3/30/2022 Class II PRODUCT Azurion systems with software release R2.0.x Recall Number: Z-0734-2022 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 Patient Type is selected...
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Company: Abbott Laboratories, Inc Date of Enforcement Report: 3/23/2022 Class II PRODUCT Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro diagnostic use only. The Alinity s System is a highthroughput, fully automated immunoassay analyzer designed to determine the presence of specific antigens and...
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Company: Brainlab AG Date of Enforcement Report: 3/16/2022 Class II PRODUCT ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 INST; 20910-01B, ETD Positioning and Moni. 1.0.2 INST; and 20910-01C ETD Positioning and Moni. 1.0.3 INST. Recall Number: Z-0733-2022 REASON The yaw angle may be incorrect...
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Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report: 3/16/2022 Class II PRODUCT RayStation/RayPlan- designed for treatment planning and analysis of radiation therapy. Software Version: 6.0.0.24 , 6.1.0.26 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.61 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 . Including Service Paks:...
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Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report: 3/16/2022 Class II PRODUCT RayStation/RayPlan- designed for treatment planning and analysis of radiation therapy. Software Version: 6.0.0.24 , 6.1.0.26 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.61 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 . Including Service Paks:...
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Company: Stryker Corporation Date of Enforcement Report: 3/16/2022 Class II PRODUCT 1688 Camera Control Unit (CCU), Catalog number: 1688010000 1688 Pendulum Camera Heads Recall Number: Z-0728-2022 REASON A software defect has been identified in the 1688 Camera Control Unit (CCU) that will cause the image on the monitor to flip upside-down into an incorrect orientation....
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IEC 62304 and Emerging Standards for Medical Device and Health IT Software DATES:  June 6-10, 2022 (New date) Clock time each day:  10 am – 3 pm US EDT (one hour break from 12:00 pm to 1:00 pm US Eastern time) COST: 5 short days for $2,200.00 – Multi-student discount available for 3 or more students...
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The U.S. FDA updated the medical device report data files, posting the Patient Problem Codes associated with “legacy Alternative Summary Report (ASR) files” on https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/mdr-data-files?utm_medium=email&utm_source=govdelivery. This update follows the addition of Patient Problem Codes to the public Manufacturer and User Facility Device Experience (MAUDE) database in September 2020 to provide additional information on the nature...
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Company: Abiomed, Inc. Date of Enforcement Report: 2/9/2022 Class I PRODUCT OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1 System consists of Console, Pump Drive, E Drive, and Pole Mount. The disposable Pump Lung Unit PLU part number 001-0400-100 is sold separately and is not part of this recall. Recall Number: Z-0550-2022 REASON...
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Company: Philips North America LLC Date of Enforcement Report: 2/9/2022 Class II PRODUCT A software tool intended for use by trained medical staff providing supplemental remote support to bedside care teams in the management and care of in-hospital patients. eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1, eCareManager version 4.5.2, eCareManager...
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Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report: 2/9/2022 Class II PRODUCT ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B Recall Number: Z-0547-2022 REASON Due to a calculation error in the measurement when using 2D trace (manual trace) tool. The trace circumference value is overestimated and may potentially result in misdiagnosis of...
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Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report: 2/2/2022 Class II PRODUCT Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000 Recall Number: Z-0515-2022 REASON Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No...
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Company: Konica Minolta Healthcare Americas, Inc. Date of Enforcement Report: 1/26/2022 Class II PRODUCT ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical images on display monitors for medical diagnostics Product number: ADFR and ADJC Recall Number: Z-0500-2022 REASON lmagePilot versions 1.92 and 1.93 paired with an AeroDR or Momentum Panel potential...
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Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report: 1/26/2022 Class II PRODUCT 1. Sensis, material # 10764561; UDI : 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo, material # 11007642; UDI: 04056869010205 Recall Number: Z-0515-2022 REASON Software error which affects Sensis Vibe Hemo, Sensis and Sensis Vibe...
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Company: Ion Beam Applications S.A. Date of Enforcement Report: 1/19/2022 Class II PRODUCT Proteus 235; Version: PTS-8 versions before PTS-8.7.2 Recall Number: Z-0466-2022 REASON Proton Therapy System (PTS) software can be started in the clinical environment (clinical user) while some processes are still running in the test environment (tcs user). Initiating the startup of the...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 1/19/2022 Class II PRODUCT SOMATOM Confidence – Computed tomography systems Model: 10590100 Recall Number: Z-0472-2022 SOMATOM Definition AS-Computed tomography system Model 8098027 Recall Number: Z-0473-2022 SOMATOM Edge Plus-Computed tomography system Model 1026700 Recall Number: Z-0474-2022 SOMATOM Definition Edge -Computed tomography system Model 10590000 Recall Number:...
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Company: Abbott Molecular, Inc. Date of Enforcement Report: 12/12/2021 Class II PRODUCT Alinity m System, Part No. 08N53-002 Recall Number: Z-0461-2022 REASON There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure. RECALLING FIRM/MANUFACTURER Abbott Molecular, Inc. on 12/6/2021. Voluntary: Firm initiated VOLUME OF PRODUCT...
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Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 12/12/2021 Class II PRODUCT Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11067000 Recall Number: Z-0449-2022 REASON (1)Software (SW) versions V1.25.1 and lower may result...
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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...
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Company: Intuitive Surgical, Inc. Date of Enforcement Report: 12/5/2021 Class II PRODUCT da Vinci SP Surgical systems with the following Model Name/ Model Number/ UDI: ASSY,PSS,SP1098,P4/ 380601-44/ 00886874114605 ASSY,SSC,SP1098,P4/ 380940-44 / 00886874114735 ASSY,VSS,SP1098,P4/ 380941-44 / 00886874114742 SOFTWARE, SYSTEM EMBEDDED RLS, SP1098, B70_P4_B327 (OS4 v4.0.0 (P4_B327) / 610112-327 / N/A Recall Number: Z-0419-2022 REASON Issue was...
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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...
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Company: Philips Healthcare Date of Enforcement Report: 12/1/2021 Class II PRODUCT Philips Azurion systems with software releases 2.1(L1) and 2.1(L2) Recall Number: Z-0238-2022 REASON 3D-RA is a reconstruction software product that can be used with the Philips Azurin system. This product extends the functionality of compatible X-ray equipment with the capability of 3D X-ray imaging....
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 12/1/2021 Class II PRODUCT Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094135 Recall Number: Z-0296-2022 Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model...
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Company: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Date of Enforcement Report: 12/1/2021 Class II PRODUCT Medtronic CareLink SmartSync Device Manager application software (D00U005) used by Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds): Cobalt XT VR: DVPA2D1, DVPA2D4; Cobalt VR: DVPB3D1, DVPB3D4; Cobalt XT DR: DDPA2D1, DPA2D4;...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 12/1/2021 Class II PRODUCT SOMATOM Force with software syngo.CT VB20 Model #10742326 Recall Number: Z-0283-2022 SOMATOM Definition AS with software syngo.CT VB20 Model #8098027 Recall Number: Z-0284-2022 SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000 Recall Number: Z-0285-2022 SOMATOM Definition Flash with software syngo.CT...
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Company: Abbott Laboratories Date of Enforcement Report: 12/1/2021 Class II PRODUCT ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74; ARCHITECT i2000 REF 08C89-01/1G17 and 8C89 Recall Number: Z-0271-2022 ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25; ARCHITECT c8000 REF 01G06-11/1G06; ARCHITECT c16000 REF 03L77-01/3L77; Recall Number: Z-0272-2022 REASON Twelve software-related issues affecting software...
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Company: Philips North America Llc Date of Enforcement Report: 11/17/2021 Class II PRODUCT Philips Azurion Interventional Fluoroscopic X-Ray System Software version: 2.1.x Model numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, Azurion 7...
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Company: Baxter Healthcare Corporation Date of Enforcement Report: 11/17/2021 Class II PRODUCT Hemodialysis Delivery System, Software Version 2.x. Recall Number: Z-0215-2022 REASON If the operator initiates therapy with a saved prescription profile and makes a change to the prescription after a disposable filter change using the Same Patient button, the system may suggest values from...
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When considering software process and software validation requirements for product software versus tool software, it can be very confusing and challenging.  We have created a job aid that can help facilitate the discussion of the differences between the two.  Available to our premium (or higher) level subscribers. The QSR which requires that “when computers or...
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Company: FujiFilm Healthcare Americas Corporation Date of Enforcement Report: 11/10/2021 Class II PRODUCT Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3 Recall Number: Z-0189-2022 Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3 Recall Number: Z-0190-2022 Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3 Recall Number: Z-0191-2022 Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0 Recall...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 11/10/2021 Class II PRODUCT Artis zeego, Fluoroscopic X-Ray System: Models: 10280959,10502505, 10848283 in combination with the following workplace/system application software models: Product/Model #: syngo X Workplace, 10281061 syngo X Workplace, 10281299 syngo X Workplace, 10502522 Syngo Application Software, 10848815 Recall Number: Z-0200-2022 REASON Software error,...
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IEC 62304 and other emerging standards for Medical Device and HealthIT Software

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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.

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