Guiding clients to effective and efficient compliance and regulatory approvals

This content is only available to Premium subscribers.  See our Subscribe page for information on subscriptions. As more "software as a medical device" (SaMD) applications are developed and marketed, there has been an increased focus on what activities and documentation are required for compliance with US medical device regulations and applicable ISO standards.  Along with...
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ARCOS Project
The US Defense Advanced Research Projects Agency (DARPA) have released a solicitation for the “Automated Rapid Certification of Software (ARCOS)” project.  The project goal is to automate system risk assessment based on software assurance.  The project recognizes that current practices in this area rely upon human judgement which can be prone to error but also...
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Company: GE Healthcare, LLC Date of Enforcement Report: 6/19/2019 Class II PRODUCT GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a) 2052831-00x b) 2050578-0xx c) 2090228-002 d) 2052782-00x Recall Number: Z-1781-2019 REASON There is a potential that one or more image series (i.e., all images within an image...
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Company: Philips North America, LLC Date of Enforcement Report: 6/19/2019 Class III PRODUCT Philips Patient Information Center iX configured with a regional setting which uses a comma for a decimal separator: 866389 Patient Information Center iX B.01 (or later); 866390 Patient Information Center iX B.01 upgrade (or later) Product Usage: The intended use of the...
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Company: Terumo Cardiovascular Systems Corporation Date of Enforcement Report: 6/19/2019 Class II PRODUCT Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #: 801188, UDI 00886799000588. Used in cardio-pulmonary bypass. Recall Number: Z-1769-2019 REASON An intermittent failure which causes a blender initialization fault upon start-up or during an EPGS calibration...
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Company: Conformis, Inc. Date of Enforcement Report: 6/19/2019 Class II PRODUCT Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT) Recall Number: Z-1775-2019 Recall Number: Z-1776-2019 REASON Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/head lengths and the resulting neck/head lengths in the manufactured implants. RECALLING...
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Company: Medtronic Neuromodulation Date of Enforcement Report: 6/19/2019 Class II PRODUCT InterStim(TM) System, Model Numbers: a) TH90G01 b) TH90GFA c) TH90G02 d) TH90G03 Product Usage: The Medtronic Model A510 Clinician application (app) is intended for use with the HH90 Handset and TM90 Communicator to program, adjust, and troubleshoot the Medtronic Models 3023 and 3058 InterStim...
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Company: One Lambda Inc Date of Enforcement Report: 6/19/2019 Class II PRODUCT UniMatch Plus Software (Catalog ID 790111 and A10286, Version 6.0) when used in association with CHR_005_201807v1.uch Recall Number: B-0675-2019 REASON The UniMatch Plus Software, containing incorrect allele specificity information, which may result in an ambiguous result or a mistyping, was distributed. RECALLING FIRM/MANUFACTURER...
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Another useful reference for establishing a safety culture in your software organization. “The purpose of this Handbook is to define the NASA Safety Culture Program and to provide guidance in the development and implementation—sustainment, growth, and practice—of Safety Culture at the Center level. It defines the NASA Safety Culture Model, describes the Safety Culture Survey...
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This content is only available to Premium subscribers.  See our Subscribe page for information on subscriptions. This template is conceived as a partial example template for a generic small device with embedded real time control. Explanatory comments are included in << comment >>. Other text is example definition that you should replace with your own...
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Company: Fresenius Medical Care Renal Therapies Group, LLC Date of Enforcement Report: 6/12/2019 Class III PRODUCT 2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 – Product Usage: The 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy in a healthcare facility. Recall Number: Z-1699-2019 REASON Power Logic Board Fail Message on the...
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Company: Philips North America, LLC Date of Enforcement Report: 6/12/2019 Class II PRODUCT IntelliVue MX40 Patient Monitor, Product number 865350, Service # USA: 453564262491 and 453564262511 – Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is connected...
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Company: Flowonix Medical Inc Date of Enforcement Report: 6/12/2019 Class II PRODUCT Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No. 12828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion. Recall Number: Z-1712-2019 Prometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, used with Prometra and Prometra II Programmable Pumps. For...
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This content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. A SoftwareCPR example for software release note and revision history.  Software Revision Level History Example
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Advanced Botanical Consulting & Testing Inc dba ABC Testing Product: Drugs Date: 6/11/19 CMS Number: 572991 The U.S. Food and Drug Administration (FDA) inspected your contract testing laboratory, Advanced Botanical Consulting and Testing Inc. dba ABC Testing (FEI 3003693795) at 1169 Warner Ave, Tustin, California, from November 1 to 13, 2018. This warning letter summarizes...
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Company: Abbott Laboratories Inc. (St Jude Medical) Date of Enforcement Report: 6/5/2019 Class II PRODUCT TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part Numbers: 600043767 (China), 100154367 (Global), 100154368 (SWAP) Recall Number: Z-1493-2019 REASON In reported cases, the device log on the TactiSys Quartz Equipment operating on Software Version 1.7.0 fills the...
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Company: Change Healthcare Israel Ltd. Date of Enforcement Report: 6/5/2019 Class II PRODUCT Horizon Cardiology Hemo: Software version 11.x and 12.x Recall Number: Z-1489-2019 Software version 13.x Recall Number: Z-1490-2019 REASON users are not notified of procedure medication discrepancies between the Vitals and Meds, the Procedure Notes and Patient Common Data screens in Horizon/McKesson Cardiology...
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This 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, SoftwareCPR Standards Navigator keeps you up to date on...
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Company: Beckman Coulter Inc. Date of Enforcement Report: 5/29/2019 Class I PRODUCT UniCel DxH 900 Coulter Cellular Analysis System, REF number C11478 Product Usage: Note: The DxH 900 hematology analyzer is CLIA categorized under document CR180294 and is currently marketed as a member of the instrument family of the DxH 800 cleared under K140911, per...
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Company: Neusoft Medical Systems Co., Ltd. Date of Enforcement Report: 5/29/2019 Class II PRODUCT NeuViz 64 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray system featuring a continuously rotating x-ray tube and detector array. The acquired x-ray transmission data is reconstructed by...
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Company: KaVo Dental Technologies LLC Date of Enforcement Report: 5/29/2019 Class II PRODUCT DEXIS Titanium Intraoral Sensor Product Usage: The DEXIS Titanium Intraoral Sensor is a USB-driven sensor which is intended to acquire dental intraoral radiographic images. The DEXIS / KaVo sensor shall be operated by healthcare professionals, who are educated and competent to perform...
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Company: Elekta Instrument AB Date of Enforcement Report: 5/29/2019 Class II PRODUCT Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning. Recall Number: Z-1412-2019 REASON The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume. RECALLING FIRM/MANUFACTURER Elekta Instrument AB...
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Company: Roche Diagnostics Corporation Date of Enforcement Report: 5/29/2019 Class II PRODUCT Cobas infinity central lab IT solution Material Number: 07154003001 Calculator/Data Processing Module, For Clinical Use Recall Number: Z-1368-2019 REASON Using the following versions of cobas infinity software (2.0 thorough 2.5), there is a potential where the results from the first sample subsequent to...
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Company: Philips North America, LLC Date of Enforcement Report: 5/22/2019 Class II: PRODUCT SureSigns VS3 NBP, Product Number 863069. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature). Recall Number: Z-1317-2019 SureSigns VS3 NBP Temp, Product Number 863070. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature). Recall Number: Z-1318-2019 SureSigns...
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Company: Becton Dickinson & Co. Date of Enforcement Report: 5/22/2019 Class II: PRODUCT BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Veritor System Test Devices. Catalog Number: 256066 Recall Number: Z-1313-2019 BD Veritor System Reader -In Vitro Diagnostic for use with BD Veritor System Test Kit Devices Catalog Number: 256055 Recall...
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