Guiding clients to effective and efficient compliance and regulatory approvals

Company: Brainlab AG Date of Enforcement Report: 10/14/2020 Class II PRODUCT Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x Product Usage: intended to be an intra-operative image guided localization system to enable minimally invasive surgery. Recall Number: Z-0056-2021 REASON Brainlab Ultrasound Navigation Software does not support the modification of...
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Our internal cybersecurity expert Gwen contributed the following. The Use of LIS2 In Medical Devices LIS2-A2 is widely used in laboratory devices as a standard practice for Healthcare Delivery Organizations (HDOs). The LIS and LIS2 communication protocol standards published nearly two decades ago have often been used in medical device network systems due to their...
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Company: Devicor Medical Products Inc Date of Enforcement Report: 10/14/2020 Class III PRODUCT Neoprobe GDS Control Unit, Model Number NPCU3 Recall Number: Z-0070-2021 REASON It was discovered during a documentation review that China has the software version as v5.01 approved for use in China. The current software version on devices distributed in China since 2011...
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In 2018, Google Health began a program in Thailand to screen for diabetic retinopathy using artificial intelligence (AI). The AI was designed to analyze photos of diabetic patients’ eyes to detect signs of eye disease. The AI was promising in theory – during testing, it was 90% accurate in detecting diabetic retinopathy in eye scans,...
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Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report: 10/7/2020 Class II PRODUCT Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATOM Force (Model #10742326) SOMATOM Definition As (Model #8098027) SOMATOM Definition Edge (Model #10590000) SOMATOM Definition Flash (Model #10430603) SOMATOM Drive (Model #10431700) SOMATOM Confidence (Model #10590100) SOMATOM Edge Plus (Model...
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Company: Blood Bank Computer Systems, Inc Date of Enforcement Report: 10/7/2020 Class II PRODUCT ABO QuickPass Web Portal, Version 1.2.0; ABO QuickPass Web Portal 1.1.0; ABO QuickPass Web Portal 1.0.0 Recall Number: B-0697-2020 REASON Blood Bank software, with a defect or glitch, was distributed. RECALLING FIRM/MANUFACTURER Blood Bank Computer Systems, Inc. on 9/16/2020. Voluntary:  Firm...
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SoftwareCPR September 2020 Newsletter has been published.  FDA news, regulatory updates, new SoftwareCPR content, software recalls, and software warning letters.
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A German woman died with “ransomware attack” as a contributing factor in preventing her from receiving timely care. Media reports indicate that it may be the first death directly linked to a cyberattack on a hospital.  Apparently the closest hospital was under the ransomware attack and could not receive the emergency patient causing the first...
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Company: Inpeco S.A. Date of Enforcement Report: 9/23/2020 Class II PRODUCT FlexLab (FLX) with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Laboratory Automation system – Product Usage: The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to...
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Brazil eliminates a premarket approval pathway, instead allowing for premarket notification. Previously, Brazil has had a “Cadastro” pathway to register Class II medical devices and IVDs. This pathway required more extensive documentation (like a technical dossier) for Class II and higher-risk Class I devices. However, on September 18, 2020, the Brazilian regulatory agency, National Health...
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Company: Life Technologies Corporation Date of Enforcement Report: 9/23/2020 Class II PRODUCT The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem’s COVID-19 Interpretive Software v1.2 for 7500 RTPCR instruments, includes the assays and controls for a multiplex real-time RT-PCR test for the qualitative detection of RNA from SARS-CoV-2 in upper respiratory specimens and bronchoalveolar lavage specimens...
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Company: Medtronic Inc. Date of Enforcement Report: 9/23/2020 Class II PRODUCT The Guardian Connect App CSS7200 iOS – Product Usage: intended for use by patients with a compatible consumer mobile device. Recall Number: Z-2980-2020 REASON As a result of the release of new software version to CareLink Personal website, the IOS app for the Continuous...
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Company: Novarad Corporation Date of Enforcement Report: 9/23/2020 Class II PRODUCT NovaPACS Diagnostic Viewer. NovaPACS is a picture archiving and communication system software that retrieves, distributes, and display images and data from different modalities including CT, MR, US, CR/DX, NM, PT, and XA. Recall Number: Z-2956-2020 REASON The firm received a report of an atypical...
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This content is only available to our Premium subscribers. See our Subscribe page for information on subscriptions. Raffaele Caliri and Jordan Pate have recently updated our 62366-1 Assessment Checklist to align with the 2020 amendment.  This version of the standard has been pared down a bit and looks a lot different than the familiar 2008 version...
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62304 Public Training Course DATES:  December 22-24, 2020 (Registration is open through December 9, 2020 as seats remain.) COST: 3 Full Days for $2,100.00 Company Discount:  3 or more register and get $200/person off (up to course size limit) This 62304 Public Training Course provides a clear understanding of the 62304 standard for medical device...
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62304 Training
62304 Public Training Course DATES:  September 22-24, 2020 (Registration is open through September 21, 2020 as seats remain.) COST: 3 Full Days for $2,100.00 Company Discount:  First two students at full price and then 10% off for any others (up to course size limit) This 62304 Public Training Course provides a clear understanding of the...
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Company: SICAT GMBH & CO. KG Date of Enforcement Report: 9/16/2020 Class II PRODUCT SICAT IMPLANT V2.0 Recall Number: Z-2951-2020 REASON A dentist found implant positions are not correctly exported from the implant planning software SICAT IMPLANT V2.0 – for the specific export format CMG.DXD. RECALLING FIRM/MANUFACTURER SICAT GMBH & CO. KG on 7/15/2020. Voluntary: ...
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Company: Merge Healthcare, Inc. Date of Enforcement Report: 9/16/2020 Class II PRODUCT Merge PACS Recall Number: Z-2944-2020 REASON Measurements done on the Merge PACS generated MPR s may have incorrect measurements. RECALLING FIRM/MANUFACTURER Merge Healthcare, Inc. on 8/6/2020. Voluntary:  Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 125 total units DISTRIBUTION U.S. Nationwide...
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Company: CareFusion 303, Inc. Date of Enforcement Report: 9/16/2020 Class I PRODUCT BD Alaris System; Alaris PCA Model 8120; P/N P0000031; Rx Only. Infusion pump for Patient Controlled Analgesia. Recall Number: Z-2882-2020 REASON The Alaris PC unit to display incorrect syringe type and/or syringe sizes. This could potentially result in delays in infusion, under-infusion, or...
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On September 14, 2020 the Digital Health Team at FDA provided a 2020 Update on the Software Precertification Pilot Program. The announcement is a short 8-page document. The document provides the details that are driving program development. It contains a considerable amount of information that may take a few reads to fully understand. On my...
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Do you have a medical device cleared under Emergency Use Authorization (EUA) during the COVID-19 crisis? Section 564 of the FD&C Act allows the FDA to issue EUAs to otherwise unapproved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents...
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The Therapeutic Goods Administration (TGA), the regulatory body for therapeutic goods in Australia, had previously announced that various medical device reforms would be enacted from 2019 through 2024. The transition period was (and still is) set to end on October 31, 2024. However, this summer, TGA announced a delay in the commencement of the medical device...
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Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report: 9/2/2020 Class II PRODUCT E.cam or Symbia systems that use foresight detectors – Product Usage: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to...
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Company: Canon Medical System, USA, Inc. Date of Enforcement Report: 9/2/2020 Class II PRODUCT System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147 Recall Number: Z-2885-2020 REASON During a procedure, when images were acquired, and these images were transferred to PACS /image archival system, the number of images displayed were not the...
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Company: Biosense Webster (Israel), Ltd. Date of Enforcement Report: 9/2/2020 Class II PRODUCT CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module – Product Usage: FGThe intended use of the system is catheter-based cardiac electrophysiological (EP) procedures. The system provides information about the electrical activity of the heart and about catheter location during the procedure....
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What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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