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AAMI Post Market Risk Management Report
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Company: Philips Healthcare Date of Enforcement Report: 12/1/2021 Class II PRODUCT Philips Azurion systems with software releases 2.1(L1) and 2.1(L2) Recall Number: Z-0238-2022 REASON 3D-RA is a reconstruction software product that can be used with the Philips Azurin system. This product extends the functionality of compatible X-ray equipment with the capability of 3D X-ray imaging....
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 12/1/2021 Class II PRODUCT Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094135 Recall Number: Z-0296-2022 Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model...
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Company: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Date of Enforcement Report: 12/1/2021 Class II PRODUCT Medtronic CareLink SmartSync Device Manager application software (D00U005) used by Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds): Cobalt XT VR: DVPA2D1, DVPA2D4; Cobalt VR: DVPB3D1, DVPB3D4; Cobalt XT DR: DDPA2D1, DPA2D4;...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 12/1/2021 Class II PRODUCT SOMATOM Force with software syngo.CT VB20 Model #10742326 Recall Number: Z-0283-2022 SOMATOM Definition AS with software syngo.CT VB20 Model #8098027 Recall Number: Z-0284-2022 SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000 Recall Number: Z-0285-2022 SOMATOM Definition Flash with software syngo.CT...
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Company: Abbott Laboratories Date of Enforcement Report: 12/1/2021 Class II PRODUCT ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74; ARCHITECT i2000 REF 08C89-01/1G17 and 8C89 Recall Number: Z-0271-2022 ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25; ARCHITECT c8000 REF 01G06-11/1G06; ARCHITECT c16000 REF 03L77-01/3L77; Recall Number: Z-0272-2022 REASON Twelve software-related issues affecting software...
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Company: Philips North America Llc Date of Enforcement Report: 11/17/2021 Class II PRODUCT Philips Azurion Interventional Fluoroscopic X-Ray System Software version: 2.1.x Model numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, Azurion 7...
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Company: Baxter Healthcare Corporation Date of Enforcement Report: 11/17/2021 Class II PRODUCT Hemodialysis Delivery System, Software Version 2.x. Recall Number: Z-0215-2022 REASON If the operator initiates therapy with a saved prescription profile and makes a change to the prescription after a disposable filter change using the Same Patient button, the system may suggest values from...
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Company: FujiFilm Healthcare Americas Corporation Date of Enforcement Report: 11/10/2021 Class II PRODUCT Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3 Recall Number: Z-0189-2022 Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3 Recall Number: Z-0190-2022 Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3 Recall Number: Z-0191-2022 Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0 Recall...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 11/10/2021 Class II PRODUCT Artis zeego, Fluoroscopic X-Ray System: Models: 10280959,10502505, 10848283 in combination with the following workplace/system application software models: Product/Model #: syngo X Workplace, 10281061 syngo X Workplace, 10281299 syngo X Workplace, 10502522 Syngo Application Software, 10848815 Recall Number: Z-0200-2022 REASON Software error,...
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Company: Medtronic Neuromodulation Date of Enforcement Report: 11/10/2021 Class II PRODUCT Clinician Programmer Application (CPA) model A610 Clinician Software Application Recall Number: Z-0201-2022 REASON A software anomaly may occur with the clinician programmer application. RECALLING FIRM/MANUFACTURER Medtronic Neuromodulation on 9/23/2021. Voluntary:  Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 3302 DISTRIBUTION U.S. Nationwide...
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Nothing software specific in this guidance, Manufacture-of-Blood-Components-Using-Pathogen-Reduction-Device-2021, but in the future one might envision that the validation and quality control could be automated by software. Purpose of the document is to provide guidance to establishments that collect or process blood and blood components, with recommendations for implementing a pathogen reduction device for the manufacture of...
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Company: MEDTECH SAS Date of Enforcement Report: 11/3/2021 Class I PRODUCT ROSA One 3.1 Brain application: The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instruments during brain and spine surgeries. Recall Number: Z-0118-2022 REASON The firm has...
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Company: AB SCIEX Date of Enforcement Report: 11/3/2021 Class II PRODUCT Cliquid MD (Version 3.4) software used in conjunction with Analyst MD software on SCIEX Citrine & 4500MD series liquid chromatography-tandem mass spectrometry (LC-MS/MS) systems. Model No. 5088288 Recall Number: Z-0175-2022 REASON The values of the Internal Standard (IS) concentrations are incorrectly derived when the...
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Company: Xstrahl Limited Date of Enforcement Report: 11/3/2021 Class II PRODUCT Concerto User Interface Software provided with the following systems: (1) Xstrahl 100 Electronic Brachytherapy – 100kV Superficial X-Ray Therapy System; (2) Xstrahl 150 Electronic Brachytherapy – 150kV Superficial X-Ray Therapy System; (3) Xstrahl 200 – 225kV Superficial / Orthovoltage X-Ray Therapy System; (4) Xstrahl...
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Today, the U.S. Food and Drug Administration (FDA) issued the draft guidance: Content of Premarket Submissions for Device Software Functions. The draft guidance is intended to reflect FDA’s most current thinking on the recommended documentation sponsors should include in premarket submissions for FDA’s evaluation of the safety and effectiveness of device software functions, including both...
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Company: Zimmer Biomet Date of Enforcement Report: 10/29/2021 Class I PRODUCT ROSA One 3.1 Brain Application: The ROSA One 3.1 Brain Application is a robotic platform that helps neurosurgeons with positioning medical instruments or implants during surgery. The device is composed of a compact robotic arm and a touch screen mounted on a stand. Different...
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Company: Medtronic Neuromodulation Date of Enforcement Report: 10/29/2021 Class I PRODUCT ROSA One 3.1 Brain Application: The ROSA One 3.1 Brain Application is a robotic platform that helps neurosurgeons with positioning medical instruments or implants during surgery. The device is composed of a compact robotic arm and a touch screen mounted on a stand. Different...
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“From my 25 years at the agency, I completely understand that FDA CDRH guidance development, approval and publication is complex, time-consuming work. I often said it may be compared to threading 1000 needles simultaneously. It requires significant time and energy from many hard-working, dedicated professionals to even reach the first goal of published draft guidance....
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Company: Philips Ultrasound Inc Date of Enforcement Report: 10/27/2021 Class II PRODUCT EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232 Recall Number: Z-0123-2022 REASON Ultrasound system software issue can cause an EchoNavigator error notification, leading to an unresponsive system, necessitating system restart, which could lead to therapy/treatment delay and/or unnecessary therapy/treatment. Can occur during ultrasound-guided...
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Company: Canon Medical System, USA, INC. Date of Enforcement Report: 10/27/2021 Class II PRODUCT Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A Recall Number: Z-0142-2022 REASON A software problem has been identified which could result in the diagnostic imaging system not proceeding to the next actual scan even though automatic start of the next scan is...
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The FDA CDRH announced the guidance documents they intend to publish in FY2022. They also announced their intention to finalize, withdraw, re-open the comment period, or re-issue a revised draft guidance for 80 percent of draft guidance documents within 3 years of the close of the comment period, and within 5 years of the close...
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Company: GE Healthcare, LLC Date of Enforcement Report: 10/27/2021 Class II PRODUCT SIGNA Premier Recall Number: Z-0132-2022 SIGNA Architect Recall Number: Z-0133-2022 SIGNA Pioneer Recall Number: Z-0134-2022 Discovery MR750w 3.0T Recall Number: Z-0135-2022 Discovery MR750 3.0T Recall Number: Z-0136-2022 SIGNA Creator, SIGNA Explorer Recall Number: Z-0137-2022 SIGNA Voyager Recall Number: Z-0138-2022 SIGNA Artist Recall Number:...
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September 17, 2021 CMS 617922 Excerpts from a warning letter of interest to software professionals: “The United States Food and Drug Administration (FDA) conducted an inspection of your medical device operations at 200 W. Mercer Street, Suite 500, Seattle, WA 98119 from June 3, 2021 through July 15, 2021. During the inspection, an FDA Investigator...
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Company: Draeger Medical, Inc. Date of Enforcement Report: 10/20/2021 Class II PRODUCT Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult, pediatric and neonatal patients. Catalog Number: 8416400 Recall Number: Z-0108-2022 REASON Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of...
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Company: BioMerieux SA Date of Enforcement Report: 10/20/2021 Class II PRODUCT MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System Recall Number: Z-0084-2022 REASON Under certain conditions, there is a risk for a false negative result. RECALLING FIRM/MANUFACTURER BioMerieux SA on 9/2/2021. Voluntary:  Firm Initiated recall is ongoing. VOLUME OF PRODUCT...
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Company: Elekta Inc. Date of Enforcement Report: 10/6/2021 Class II PRODUCT Elekta Monaco – Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy. Recall Number: Z-2563-2021 REASON Contour changes can be saved on an unintended image set. In addition, these contour edits do not cause the dose to...
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Company: Biodex Medical Systems, Inc. Date of Enforcement Report: 10/6/2021 Class II PRODUCT Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330. Recall Number: Z-2580-2021 REASON When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes may then have...
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Company: Philips Ultrasound Inc. Date of Enforcement Report: 9/29/2021 Class II PRODUCT EPIQ Diagnostic Ultrasound Systems: Software Versions: 5.0, 5.0.1 and 5.0.2 Models: EPIQ 5 – 795120, EPIQ 5C – 795205, EPIQ 5G – 795204, EPIQ 7 – 795117, EPIQ 7C – 795201, EPIQ 7G – 795200, EPIQ CVxi -795232, EPIQ CVx – 795231 Recall...
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Company: Philips Ultrasound Inc. Date of Enforcement Report: 9/29/2021 Class II PRODUCT Affiniti Diagnostic Ultrasound Systems: Software Versions: 5.0, 5.0.1 and 5.0.2 Models: Affiniti 30 795121, Affiniti 30 795218, Affiniti 50 795208, Affiniti 50 795118, Affiniti 70 795210, Affiniti 70 795119 Recall Number: Z-2484-2021 REASON Due to a software defect that can intermittently cause the...
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Company: GE Healthcare, LLC Date of Enforcement Report: 9/29/2021 Class II PRODUCT Centricity PACS-IW with Universal Viewer – Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources. Recall Number: Z-2502-2021 REASON Image acquisition failures and synchronization failure with the Centricity Enterprise Archive. RECALLING FIRM/MANUFACTURER GE Healthcare, LLC...
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The virtual AAMI/FDA/BSI International Conference on Medical Devices (the ISC) will be presented from 10:30 a.m. to 3:15 p.m. (EDT), Monday-Wednesday 18-20 October 2021. As always, the ISC will be a dynamic review of recent changes and a look to what’s ahead in health tech standards and regulation, but this year each day will have...
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Company: DePuy Orthopaedics, Inc. Date of Enforcement Report: 9/8/2021 Class II PRODUCT TRUMATCH CT PIN GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number: 420578 Recall...
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Company: Elekta Inc Date of Enforcement Report: 9/8/2021 Class II PRODUCT Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10 Recall Number: Z-2406-2021 REASON If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 9/8/2021 Class II PRODUCT Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 10094139 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis...
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Company: Philips Medical Systems Gmbh, DMC Date of Enforcement Report: 9/8/2021 Class II PRODUCT CombiDiagnost R90 Software Version R1.0 and R1.1 Recall Number: Z-2357-2021 REASON Philips has become aware of a software issue, where the kV and mA values are not locked immediately but change when the collimator shutter position is changed directly after the...
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Company: Merge Healthcare, Inc. Date of Enforcement Report: 9/8/2021 Class II PRODUCT Merge Hemo, Software packages 10.2, 10.3, and 10.4 Recall Number: Z-2387-2021 REASON The firm identified a safety issue affecting the software associated with Merge Hemo versions 9.x and 10.x, used in combination with an HL7 lab interface. RECALLING FIRM/MANUFACTURER Merge Healthcare, Inc. on...
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Company: Beckman Coulter Inc. Date of Enforcement Report: 9/1/2021 Class II PRODUCT Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments. Recall Number: Z-2332-2021 REASON There is a potential that the data management system may add additional cells to...
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You may be interested in attending the FDA Virtual Public Workshop, “Transparency of Artificial Intelligence/Machine Learning-enabled Medical Devices,” planned for October 14, 2021.   Info on attending:  https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/virtual-public-workshop-transparency-artificial-intelligencemachine-learning-enabled-medical-devices  
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Company: Philips North America LLC Date of Enforcement Report: 8/25/2021 Class II PRODUCT 728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades Recall Number: Z-2314-2021 REASON When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the...
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Company: Philips Respironics, Inc. Date of Enforcement Report: 8/25/2021 Class II PRODUCT Trilogy Evo, Product numbers: BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, EE2110X15B, ES2110X15B, EU2110X15B, EU2110X19, FR2110X14B, GB2110X15B, IA2110X15B, IN2110X15B, IN2110X19, IT2110X21B, KR2110X15B, LA2110X15B, LD2110X23B, ND2110X15B, RDE2110X13B, UDS2110X11B Recall Number: Z-2287-2021 REASON Two software issues have been identified related to pressure increase in the device: The first...
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Company: Abbott Laboratories, Inc Date of Enforcement Report: 8/18/2021 Class II PRODUCT Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis screening, and organ donor centers, hospitals, and reference laboratories. Recall Number: Z-2241-2021 REASON A design defect (hardware and software) allows liquid waste...
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Company: Beckman Coulter, Inc. Date of Enforcement Report: 8/18/2021 Class I PRODUCT Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10574 – Kaluza C Single Perpetual License C10575 – Kaluza C Single User 1-year License C10576 – Kaluza C 10 User Network License C10577 – Kaluza C 5 User Network License C10578...
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Company: Baxter Healthcare Corporation Date of Enforcement Report: 8/18/2021 Class I PRODUCT Dose IQ Safety Software used with Spectrum IQ Infusion Pump Recall Number: Z-2165-2021 REASON Software issue: The defect creates a mismatch between linked drug identifiers (IDs) in the Dose IQ user interface (UI) and the binary drug library (BDL) loaded onto the Spectrum...
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Company: Simpleware Product Group, SYNOPSYS NORTHERN EUROPE Date of Enforcement Report: 8/18/2021 Class II PRODUCT Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options. Recall Number: Z-2253-2021 REASON A issue (bug) has been identified with the interface and image software which could...
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Company: Baxter Healthcare Corporation Date of Enforcement Report: 8/18/2021 Class I PRODUCT Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids. Recall Number: Z-2110-2021 REASON System errors were noted following changes the customers implemented to the configuration of their network and server systems. Gateway Server System...
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Company: BioMerieux SA Date of Enforcement Report: 8/18/2021 Class II PRODUCT MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results by transferring, storing, and displaying medical device data. Recall Number: Z-2225-2021 REASON Software anomaly – Under certain conditions, unwanted alterations to results could be applied when...
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IEC 62304 and Emerging Standards for Medical Device and Health IT Software DATES:  Oct 19-21, 2021 Clock time each day:  8:30 am – 4:30 pm US Pacific COST: 3 Full Days for $2,100.00 (Early Bird discount: $1595 thru September 1, 2021) Special FDA / Government rate:  $500 (contact us at training@softwarecpr.com to qualify) Multi-student discounts available....
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The US FDA released the 2022 user fees for certain medical device submissions and establishment registration. On August 2, 2021, the FDA announced the FY2022 user fees in a Federal Register notice titled Medical Device User Fee Rates for Fiscal Year 2022. FY2022 User fees are required for the following types of medical device submissions:...
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Probabilistic Genotyping Used for Criminal Prosecution In a recent article published on The Markup, software that is used to match DNA in criminal prosecution has come under scrutiny.  The software implements what is known as probabilistic genotyping, a method used when analyzing data that contains a mixture of DNA from multiple people.  The software uses complex...
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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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