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Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 11/18/2015 Class lI: PRODUCT MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis. Recall Number Z-0265-2016 REASON Display freeze of MODULARIS hand control results in information not being updated on the display. Current treatment data is not shown to the user. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA,...
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Company: GE Healthcare.Date of Enforcement Report 11/18/2015 Class lI: PRODUCT GE Healthcare, Discovery MR750w 3.0T. Product Usage: The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T Systems are whole body magnetic resonance scanners for diagnostic imaging. Recall Number Z-0254-2016 REASON When performing head or neck scans, the currently displayed...
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A new International Medical Device Regulators Forum (IMDRF) document was finalized.  It is Software as a Medical Device (SaMD): Application of Quality Management System.  The objective of the document is to provide guidance on the application of existing standardized and generally accepted QMS practices to SaMD. View the document at this link:  imdrf-tech-151002-samd-qms
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Company: Hamilton.Medical Date of Enforcement Report 8/26/2015 Class l: PRODUCT The G5 ventilator provides breathing support for adult, children, infant and newborn patients. The device is intended for use in hospital and other health care facilities. It may be used for transport within a hospital or health care facility. REASON The ventilator may stop working,...
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Paul Felten of SoftwareCPR has successfully passed the ISTQB Agile Tester Certification exam. The ISTQB Agile Tester certification was created to account for new emerging practices and methodology changes in the software testing industry. Based on the foundation level syllabus, this certification ensures that software testers and professional alike have the necessary knowledge and skills...
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Company: Otto Bock Healthcare GmbHG Date of Enforcement Report 11/11/2015 Class lI: PRODUCT iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle; 1C66* Triton Smart Ankle. Recall Number Z-0209-2016 REASON Otto Bock Healthcare GmbH has identified a software issue where the foot can produce an undesired response (can move into dorsiflexion)...
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Company: Steris Corporation Date of Enforcement Report 11/11/2015 Class lI: PRODUCT AMSCO 400 and AMSCO C Small Steam Sterilizers Recall Number Z-0210-2016 REASON In AMSCO Small Steam Sterilizers equipped with the CS-iQ feature, the sterilizer software inadvertently prevents the capability to operate the foot pedal, which allows the Operator to open and close the sterilizer...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 11/11/2015 Class lI: PRODUCT Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A Recall Number Z-0204-2016 REASON 1. Device will perform the weekly automated tests hourly, which could cause the therapy capacitors to degrade sooner than intended and 2. While connected to AC or DC power and...
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Company: GE Healthcare.Date of Enforcement Report 11/11/2015 Class lI: PRODUCT The Centricity Universal Viewer Version is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Typical users of this system...
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Company: Ortho-Clinical Diagnostics Date of Enforcement Report 11/11/2015 Class lI: PRODUCT VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number/Product Code 6801890, Unique Device Identifier No. 10758750001644. Intended for use in the in vitro quantitative measurement of a variety of analytes...
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Company: Brainlab AG Date of Enforcement Report 11/11/2015 Class lI: PRODUCT Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient Data Manager is a system intended for the display of medical images. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media. It...
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Company: GE Healthcare.Date of Enforcement Report 11/11/2015 Class lI: PRODUCT The Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Typical users of this...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 11/11/2015 Class lI: PRODUCT HeartStart MRx monitor/defibrillator Models M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the...
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http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/GlobalUDIDatabaseGUDID/UCM396595.pdf
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Company:Elekta Inc.Date of Enforcement Report: 11/4/2015 Class lI: PRODUCT Monaco – Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam radiation therapy. Recall Number Z-0181-2016 REASON Unintended update of Dose and MU and Incorrect Assignment of Bolus. RECALLING FIRM/MANUFACTURER Elekta Inc., Atlanta, GA on 10/16/2015 Voluntary: Firm Initiated recall...
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Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 11/4/2015 Class lI: PRODUCT ACUSON SC2000 ultrasound systems model 10433816 Imaging system that provides the ability to measure anatomical structures and calculation packages that provide info for clinical diagnosis purposes.Recall Number Z-0182-2016 REASON Siemens will provide all customers a new version of system software (VA35E or VB10C...
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Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 11/4/2015 Class lI: PRODUCT CIOS ALPHA; image intensified fluoroscopic x-ray system Recall Number Z-0118-20166 REASON patient procedure interruption due to a potential system failure RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc, Malvern, PA on 8/7/2015 Voluntary: Firm Initiated recall is ongoing VOLUME OF PRODUCT IN COMMERCE 44...
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Company: Perkin Elmer Life Sciences Inc. Date of Enforcement Report 11/4/2015 Class lI: PRODUCT Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.Recall Number Z-0166-2016 REASON It would be possible for an abnormal analytical test result value from an affected newborn...
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Company:Natus Neurology Inc.Date of Enforcement Report: 11/4/2015 Class lI: PRODUCT ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License. Model number HIT Product Usage: ARIA Radiation Oncology is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 10/28/2015 Class lI: PRODUCT All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software. Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the...
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Company:Toshiba American Medical Systems Inc.Date of Enforcement Report: 10/21/2015 Class lI: PRODUCT Toshiba Aquilion CT System TSX-301C Recall Number Z-0016-2016 REASON it was found that if two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. RECALLING FIRM/MANUFACTURER Toshiba American Medical Systems Inc., Tustin, CA on 5/8/2015 Voluntary:...
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Company:Toshiba American Medical Systems Inc.Date of Enforcement Report: 10/21/2015 Class lI: PRODUCT Toshiba Aquilion CT System TSX-302A Recall Number Z-0017-2016 REASON it was found that if two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. RECALLING FIRM/MANUFACTURER Toshiba American Medical Systems Inc., Tustin, CA on 5/8/2015 Voluntary:...
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Company:Toshiba American Medical Systems Inc.Date of Enforcement Report: 10/21/2015 Class lI: PRODUCT Toshiba Aquilion CT System TSX-303A Recall Number Z-0018-2016 REASON it was found that if two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. RECALLING FIRM/MANUFACTURER Toshiba American Medical Systems Inc., Tustin, CA on 5/8/2015 Voluntary:...
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Company:Toshiba American Medical Systems Inc.Date of Enforcement Report: 10/21/2015 Class lI: PRODUCT Toshiba Aquilion CT System TSX-101A Recall Number Z-0013-2016 REASON it was found that if two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. RECALLING FIRM/MANUFACTURER Toshiba American Medical Systems Inc., Tustin, CA on 5/8/2015 Voluntary:...
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Company:Natus Neurology Inc.Date of Enforcement Report: 10/21/2015 Class lI: PRODUCT NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne data acquisition and review system, either with or without synchronous digital video. The system is intended for medical purposes to record, measure, store and display full band (FbEEG) cerebral EEG and extracerebral activity for Clinical EEG, Electrocorticography...
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Company:Toshiba American Medical Systems Inc.Date of Enforcement Report: 10/21/2015 Class lI: PRODUCT Toshiba Aquilion CT System TSX-101A Recall Number Z-0013-2016 REASON it was found that if two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. RECALLING FIRM/MANUFACTURER Toshiba American Medical Systems Inc., Tustin, CA on 5/8/2015 Voluntary:...
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Company:Toshiba American Medical Systems Inc.Date of Enforcement Report: 10/21/2015 Class lI: PRODUCT Toshiba Aquilion CT System TSX-301B Recall Number Z-0015-2016 REASON it was found that if two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. RECALLING FIRM/MANUFACTURER Toshiba American Medical Systems Inc., Tustin, CA on 5/8/2015 Voluntary:...
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http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm457581.htm
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Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 10/14/2015 Class lI: PRODUCT SOMATOM Definition AS, intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. Recall Number Z-0021-2016 REASON software bug issues for...
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Company: Toshiba American Medical Systems Inc.Date of Enforcement Report 10/14/2015 Class lI: PRODUCT Celesteion PCA-9000A/2 PET/CT System Recall Number Z-0005-2016 REASON It was found that if specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved due to a software problem. RECALLING FIRM/MANUFACTURER Toshiba American Medical Systems Inc, Tustin,...
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Company: GE Healthcare.Date of Enforcement Report 10/14/2015 Class lI: PRODUCT Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions 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 across computer networks at distributed locations. Recall...
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Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 10/14/2015 Class lI: PRODUCT SOMATOM Force; computed tomography x-ray system. Intended to generate and process cross-sectional images of patients. Recall Number Z-0107-2016 REASON Software and firmware bugs RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc, Malvern, PA on 8/18/2015 Voluntary: Firm Initiated recall is ongoing VOLUME OF PRODUCT...
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Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 10/14/2015 Class lI: PRODUCT SOMATOM Definition Edge; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. Recall Number Z-0019-2016 REASON software bug issues for...
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Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 10/14/2015 Class lI: PRODUCT SOMATOM Definition Flash; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. Recall Number Z-0020-2016 REASON software bug issues for...
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Company:Elekta, Inc.Date of Enforcement Report: 10/14/2015 Class lI: PRODUCT Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy. Recall Number Z-0112-2016 REASON Dose and MU are incorrect when CT images are viewed from the head, and, when using multiple prescriptions with forced densities.. RECALLING FIRM/MANUFACTURER...
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Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 10/14/2015 Class lI: PRODUCT Syngo RT Oncologist, an optional accessory to the linear accelerator system and permits localization, contouring, segmentation, image review, and review and approval of treatment plan parameters. In addition, it includes tools and administrative functions to aid in the diagnosis, staging, and prescription of...
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https://www.federalregister.gov/articles/2015/10/16/2015-25597/2015-edition-health-information-technology-certification-criteria-2015-edition-base-electronic
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https://www.federalregister.gov/articles/2015/10/16/2015-25597/2015-edition-health-information-technology-certification-criteria-2015-edition-base-electronic
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A committee draft for vote has been circulated for the AAMI TIR 57 Principles for medical device information security risk management. The objective of this TIR is to provide guidance on how medical device manufacturers can manage risks from security threats that could impact the confidentiality, integrity, and/or availability of the device or the information...
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Company: Biosense Webster, Inc.Date of Enforcement Report 10/7/2015 Class lI: PRODUCT Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps. Recall Number Z-0002-2016 REASON Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed...
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Company: Biosense Webster, Inc.Date of Enforcement Report 10/7/2015 Class lI: PRODUCT SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. Recall Number Z-0003-2016 REASON Image disappeared from the cardiac ultrasound system when the...
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FDA has a series of training videos and slide presentations referred to as CDRHLearn. Under the Special Technical Topics is an IT and Software Section which lists 3 topics: Digital Health, Premarket Cybersecurity Information, and CDRH Regulated Software.
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Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 9/30/2015 Class lI: PRODUCT ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of cancer Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-Ray photon and electron radiation...
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Company: Beckman Coulter Inc. Date of Enforcement Report 9/30/2015 Class lI: PRODUCT MicroScan LabPro Information Manager System, Version 1.0 to Version 4.11, Catalog No. 10714149, 10714150. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST). Recall Number Z-2809-2015 REASON Beckman Coulter is recalling the MicroScan LabPro Information Manager System because the...
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Unimark Remedies LtdProduct: active pharmaceutical ingredients Date: 9/28/2015 Failure to prevent unauthorized access or changes to data and to provide adequate controls to prevent omission of data. Your laboratory systems lacked access controls to prevent raw data from being deleted or altered. For example: a. During the inspection, we noted that you had no unique...
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Company: Medtronic Inc. Cardiac Rhythm Disease Management Date of Enforcement Report 9/23/2015 Class lI: PRODUCT Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures. Recall Number Z-2777-2015 REASON Medtronic has identified an issue with a USB memory component contained within a subset of CryoConsoles. The issue can result in extended...
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The U.S. FBI issued a Public Service Announcement on the Internet of Things that includes, “Criminals can also gain access to unprotected devices used in home health care, such as those used to collect and transmit personal monitoring data or time-dispense medicines. Once criminals have breached such devices, they have access to any personal or...
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Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 9/23/2015 Class lI: PRODUCT ACUSON SC2000 Ultrasound System with software versions VB10B and lower; Model 10433816; Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional,...
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FDA maintains a webpage for its educational modules referred to as “CDRH Learn.”  Specialty Technical Topics provides a list with a section for IT and Software that includes three modules on Digital Health, Cybersecurity information in premarket submissions, and CDRH regulated software.
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