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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: 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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Trying to understand Software Design Verification … A QA’s takeaway on reading the General Principles of Software Validation for the first time. FDA gives guidance in the General Principles of Software Validation guidance document, but in general: Testing at different levels: units, integrated units, software complete Testing types: negative, combinatorial, fault injection, risk controls challenge, boundary, corner cases, stress,...
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FDA has released a new draft of Premarket Cybersecurity in Medical Devices:  Quality System Considerations and Content of Premarket Submissions.  Per the scope, this 2022 FDA Premarket Cybersecurity Guidance “is applicable to devices that contain software (including firmware) or programmable logic, as well as software as a medical device (SaMD). The guidance is not limited to devices...
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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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This March 2022 Standards Navigator Report content is only available to Standards Navigator subscribers. See our Subscribe page for information on subscriptions. SoftwareCPR® Standards Navigator provides information and tools related to standards that play a significant role in health software and software intensive medical devices.  In addition to information on existing standards, our report keeps you...
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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: 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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