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Company:Hitachi Ltd., Medical System Operations Group Date of Enforcement Report 5/9/2018 Class lI: PRODUCT MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated. Recall Number: Z-1585-2018 REASON Due to a system controller software anomaly, the...
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Company:PerkinElmer Life and Analytical Sciences, Wallac, OYDate of Enforcement Report 5/9/2018 Class lI: PRODUCT Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) Specimen Gate Screening Center is used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs....
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Company:Philips Electronics North America Corporation Date of Enforcement Report 5/9/2018 Class lI: PRODUCT Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional fluoroscopic x-ray system Product Usage: The Allura Xper ED series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Sensation 10 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1453-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a....
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Perspective 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1448-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a....
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Emotion (2003) Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1452-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a....
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Perspective Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1447-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior)...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Emotion 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1446-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a....
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Scope Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1449-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior)...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Scope Power Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1450-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a....
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Company:Roche Diagnostics CorporationDate of Enforcement Report 5/9/2018 Class lI: PRODUCT cobas b 221Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Perspective 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1448-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a....
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Company:Roche Diagnostics CorporationDate of Enforcement Report 5/9/2018 Class lI: PRODUCT cobas b 221Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Emotion 6 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1445-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a....
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Company:Roche Diagnostics CorporationDate of Enforcement Report 5/9/2018 Class lI: PRODUCT cobas b 221Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Sensation 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1454-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a....
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Sensation 40 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1458-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a....
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Sensation 64 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1456-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a....
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Sensation Cardiac Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1455-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a....
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT Biograph Horizon – PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner. Recall Number: Z-15972018 REASON Error introduced into PET images acquired and reconstructed with VJ20A software. Array values are indexed improperly when the norm file is created during QC. During data...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Sensation Emotion Duo (2003) Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1459-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based...
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Company:Radiometer Medical ApSDate of Enforcement Report 5/9/2018 Class lI: PRODUCT AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system is intended to let allow the management of analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from connected devices...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Sensation Open Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1457-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a....
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Spirit Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1451-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior)...
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FDA issued a draft guidance dated April 27, 2018 titled: “Multiple Function Device Products: Policy and Considerations.”  This guidance expands on when and how FDA intends to assess the impact of other functions that are not the subject of a premarket review on the safety and effectiveness of a device function subject to FDA review.  It...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 4/25/2018 Class lI: PRODUCT ONCOR Avant-garde, Digital Linear Accelerator, Model No. 05863472 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer. Recall Number: Z-1398-2018 REASON Control Console software has been updated to reduce the risk for collision...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 4/25/2018 Class lI: PRODUCT ONCOR Expression, Digital Linear Accelerator, Model No. 07360717 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer Recall Number: Z-1399-2018 REASON Control Console software has been updated to reduce the risk for collision...
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Company:GE Medical Systems Ultrasound & Primary Care Diagnostics, Date of Enforcement Report 4/25/2018 Class lI: PRODUCT GE Healthcare:a) Prodigy, Model Numbers: LU7248, LU8905, LU40427, LU40431, LU40626, LU40637, LU40626, LU40637, LU42021, LU42025, LU41730, LU41734, LU42344, LU42365 b) Prodigy Advanced, Model Numbers: LU42361, LU42397Provides an estimate of BMD (Bone Marrow Density) at the lumbar spine and proximal...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 4/25/2018 Class lI: PRODUCT ONCOR Impression plus, Digital Linear Accelerator, Model No. 07360717 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer Recall Number: Z-1401-2018 REASON Control Console software has been updated to reduce the risk for...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 4/25/2018 Class lI: PRODUCT ONCOR Impression, Digital Linear Accelerator, Model No. 07360717 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer Recall Number: Z-1400-2018 REASON Control Console software has been updated to reduce the risk for collision...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 4/25/2018 Class lI: PRODUCT PRIMUS HI, Digital Linear Accelerator, Model No. 07360717 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer Recall Number: Z-1402-2018 REASON Control Console software has been updated to reduce the risk for collision...
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Company:GE Medical Systems Ultrasound & Primary Care Diagnostics, Date of Enforcement Report 4/25/2018 Class lI: PRODUCT 1. GE Healthcare Lunar: a) DPX Duo, Model Number: LU41693 b) DPX Bravo, Model Number: LU41692 Provides an estimate of BMD (Bone Marrow Density) at the lumbar spine and proximal femur regions. This BMD value can then be compared...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 4/25/2018 Class lI: PRODUCT MEVATRON M2 / PRIMUS Mid-Energy, Digital Linear Accelerator, Model No. 01940035 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer. Recall Number: Z-1397-2018 REASON Control Console software has been updated to reduce the...
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Company:Philips Medical Systems (Cleveland) IncDate of Enforcement Report 4/25/2018 Class lI: PRODUCT ngenuity TF PET/CT, Model No. 882442 Product Usage: The device is an integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system suitable for a wide range of diagnostic applications. The device utilizes the CT technology to obtain anatomic images of...
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Company:Fresenius Medical Care Renal Therapies Group, LLCDate of Enforcement Report 4/18/2018 Class lI: PRODUCT Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device is indicated for acute and chronic peritoneal dialysis. Recall Number Z-1365-2018 REASON The recalling firm identified a software issue related to the Patient Line Check (PLC) which may result...
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Company:Beckman Coulter Inc.Date of Enforcement Report 4/18/2018 Class lI: PRODUCT BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer Recall Number Z-1362-2018 REASON Beckman Coulter has determined that there is a potential for under-reporting casts. This can occur if per high-power field (/HPF) units of measurement for casts are selected in the iQ200 software, but the abnormal...
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Company:Beckman Coulter Inc.Date of Enforcement Report 4/18/2018 Class lI: PRODUCT AQUIOS CL Flow Cytometer System, Catalog #B30166. The AQUIOS CL Flow Cytometer system is an automated analyzer that use a no-wash sample preparation process.The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland. Recall Number Z-1341-2018 REASON The device may process...
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Company:Philips Electronics North America CorporationDate of Enforcement Report 4/18/2018 Class lI: PRODUCT IntelliVue X3 Patient Monitor.. Recall Number Z-1315-2018 REASON The NBP measurement of Intellivue X3 Patient Monitor shows intermittently only mean values instead of the diastolic and systolic blood pressure values. This is caused by a falsely detected NBP cuff, which is leading to...
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Company:Beckman Coulter Inc.Date of Enforcement Report 4/18/2018 Class lI: PRODUCT iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100. Recall Number Z-1366-2018 REASON iQ200 Series Urine Microscopy Analyzer may intermittently fail to read urine sample dilution barcode labels causing erroneous results that could delay treatment for health conditions such as hematuria. RECALLING FIRM/MANUFACTURER Beckman...
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Company:Lifeline Systems Company.Date of Enforcement Report 4/18/2018 Class lI: PRODUCT HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator. Recall Number Z-1316-2018 REASON A programing error in some Model FD100 HomeSafe AutoAlert Pendants will render the fall detection feature inoperable. RECALLING FIRM/MANUFACTURER Lifeline Systems Company, Framingham, MA on 11/13/2017. Voluntary: Firm Initiated recall...
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Ron Baerg, of Seminole, FL USA, is now a partner at Crisis Prevention and Recovery LLC (DBA SoftwareCPR ®), a full service medical device compliance and premarket submissions consultancy. Ron has over twenty three years experience in medical device software development and management. His experience has been primarily focused on large, complex medical device systems...
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FDA issued a draft guidance for comment: Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Contains Nonbinding Recommendations Draft – Not for Implementation Equivalence through Performance Criteria. The outline shows a Section 17 for software information. The outline can be viewed here.
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Company:Baxter Healthcare CorporationDate of Enforcement Report 4/11/2018 Class lI: PRODUCT Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate system.Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. Recall Number Z-1280-2018 REASON Firm has received reports of device operators failing to adhere to...
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Company:GE HealthcareDate of Enforcement Report 4/11/2018 Class lI: PRODUCT GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 2049588-008 Product Usage: Centricity PACS-IW by GE Healthcare is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or...
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Company:Fresenius Medical Care Renal Therapies Group, LLCDate of Enforcement Report 4/11/2018 Class lI: PRODUCT 2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial Number), (2) Machine Short Cap, OLC.DP HP 190630, UDI 00840861100866 (+Serial Number) ndicated for acute and chronic dialysis therapy. Recall Number Z-1278-2018 REASON...
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Company:Invivo Corporation.Date of Enforcement Report 4/11/2018 Class lI: PRODUCT DynaCad software consist of an MR Analysis Server software and the viewer workstation software. The MR Analysis software consists of DynaCad Breast, DynaCad Prostate, and DynaCad Advanced PK for other MR analyses modules. Product Usage: Intended to be used as a post processing software package designed...
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Company:Phadia Ab.Date of Enforcement Report 4/11/2018 Class lI: PRODUCT Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and EliA Assays. This recall is for any Phadia Prime software version up to and including the current version, 2.1.4. Recall Number Z-1276-2018 REASON We want to inform...
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Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report 4/11/2018 Class lI: PRODUCT Syngo.via. Medical Device Software. Picture archiving and communications system Recall Number Z-1303-2018 REASON A software functionality in the report sections Findings Information and Summary of Measured Findings is not performing properly. The system will use the original values instead of displaying and saving...
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The Global Unique Device Identification Database is a database administered by the FDA that will serve as a reference catalog for every device with an identifier. May 2018 will start implementation of the releasability logic and the review period. Public release of premarket submission and supplement numbers on AccessGUDID and OpenFDA will begin in June 2018.
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Company:St. Jude Medical, Inc..Date of Enforcement Report 4/4/2018 Class lI: PRODUCT Proclaim DRG Implantable Pulse Generator, Model Number 3664 Recall Number Z-1170-2018 REASON The firm received complaints of error messages that occurred during routine impedance checks on Proclaim DRG IPGs, model 3664. Some complaints were also associated with transient over stimulation which created discomfort for...
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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 with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

Next public offering:  June 24-26, 2025 (Virtual, Live)

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Being Agile & Yet Compliant (Public)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for registration!

  • Agile principles that align well with medical
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3 days virtual (Zoom) with group exercises, quizzes, examples, Q&A.

Lead Instructor: Mike Russell

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  • TBD
See our post titled: 1st Quarter 2025 Agile Compliant Courses Scheduled

 

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.

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