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Company: BioMerieux Inc. Date of Enforcement Report 11/28/12 Class ll: PRODUCT bioMerieux BacT/ALERT 3D 60, catalog number, 248009, Clinical instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due...
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Company: BioMerieux Inc. Date of Enforcement Report 11/28/12 Class ll: PRODUCT bioMerieux BacT/ALERT Control Module, catalog number 200290,, Clinical instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due...
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Company: BioMerieux Inc. Date of Enforcement Report 11/28/12 Class ll: PRODUCT bioMerieux BacT/ALERT Control Module, catalog number 210147, Clinical instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due...
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Company: Mako Surgical Corporation Date of Enforcement Report 11/28/12 Class ll: PRODUCT The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000). The RIO is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The RIO is indicated for use...
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Company: BioMerieux Inc. Date of Enforcement Report 11/28/12 Class ll: PRODUCT 1. bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML01, Clinical instrument software, English, Spanish, Italian, catalog number 411814 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely...
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Company: BioMerieux Inc. Date of Enforcement Report 11/28/12 Class ll: PRODUCT 1. bioMerieux Kit, USB HDW, BTA3D60-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411956 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill...
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Company:Medical Information Technology, Inc Date of Enforcement Report 11/21/12 Class ll: PRODUCT MEDITECH Blood Bank Software – Client Server Releases 5.63, 5.64, 5.65, 6.0, 6.04, 6.05, 6.06, 6.1 and 6.12. Recall Number B-0101-13 REASON Blood Bank Software, with a defect or glitch, was distributed. RECALLING FIRM/MANUFACTURER Medical Information Technology, Inc., Westwood, MA on 7/24/12 Voluntary:...
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Company:Medical Information Technology, Inc Date of Enforcement Report 11/21/12 Class ll: PRODUCT MEDITECH Blood Bank Software, Client Server Releases 5.6, 5.65, 6.0,6.05, 6.06, and 6.13. Recall Number B-0102-13 REASON Blood Bank Software, with a defect or glitch, was distributed. RECALLING FIRM/MANUFACTURER Medical Information Technology, Inc., Westwood, MA on 8/20/12 Voluntary: Firm Initiated recall is ongoing...
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Company:Sunquest Information Systems, Inc. Date of Enforcement Report 11/14/12 Class ll: PRODUCT Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later. Recall Number Z-0251-2013 REASON The recall was initiated because Sunquest Information System has confirmed reports of an Outbound Phlebotomy Point of Care (POC) interface is combining patient orders inappropriately. RECALLING FIRM/MANUFACTURER...
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Company:Sechrist Industries Inc Date of Enforcement Report 11/14/12 Class ll: PRODUCT Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3300E/ER The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures. Recall Number Z-0208-2013 and Z-0209-2013 REASON Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with...
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Company:Philips Medical Systems Date of Enforcement Report 11/14/12 Class ll: PRODUCT Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc., Fitchburg, WI. Pinnacle3 Radiation Therapy Planning System is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes. Pinnacle3...
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Company:Sunquest Information Systems, Inc. Date of Enforcement Report 11/14/12 Class ll: PRODUCT Sunquest Laboratory, version 7.0 not available. Recall Number Z-0250-2013 REASON Sunquest is recalling Sunquest Laboratory version 7.0 because when saving an Accession to a non-current Episode/Event, a User-Defined field can be incorrectly replaced by the current Episode/Event User-Defined data. RECALLING FIRM/MANUFACTURER Sunquest Information...
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Company:Sendx Medical Inc Date of Enforcement Report 11/14/12 Class ll: PRODUCT ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35). The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL80 FLEX CO-OX system is intended for use by trained...
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AAMI/CDV-1 62366:2007/A1 (IEC/SC62A/826/CDV) — Medical devices – Application of usability engineering to medical devices, Amendment 1. This amendment is out for comment and addresses legacy user interfaces and 62366 conformance for User Interfaces of Unknown Provenance (UOUP). The 62366 amendment draft can now downloaded free from AAMI. Go to the AAMI web site at the...
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Company:Elekta, Inc Date of Enforcement Report 11/7/12 Class ll: PRODUCT MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management. It lets users supply electronic patient charts and assemble care plans, order diagnostic tests, and prescribe medications. It also lets users import, view, annotate, manipulate, enhance, manage, and archive images....
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Company:Heartsine Technologies, Limited Date of Enforcement Report 11/7/12 Class ll: PRODUCT HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106 Product Usage: Samaritan 300/300P PAD is indicated for use on victims of sudden cardiac arrest who are exhibiting the following signs: Unconsciousness Not breathing Without circulation. Recall...
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Company:Vital Images, Inc Date of Enforcement Report 11/7/12 Class ll: PRODUCT Software for Vitrea, Vitrea fX, and Vitrea Enterprise Suite (VES): VPMC-09293C Vitrea . Model Number Vitrea 5.2, 6.0, 6.1, and 6.2 VPMC-09346B Vitrea fX Model Number Vitrea fX 3.1, 5.2, 6.0, 6.1, and 6.2 VPMC-11731A Vitrea Enterprise Suite Model Number Vitrea Enterprise Suite 1.3,...
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Company:Varian Medical Systems, Inc. Oncology Systems Date of Enforcement Report 11/7/12 Class ll: PRODUCT ARIA Radiation Oncology, Version 11. Varian Medical Systems, Palo Alto, CA. The ARIA Radiation Oncology product is a treatment plan and image management application. Recall Number Z-0187-2013 REASON An anomaly has been identified with the ARIA Oncology Information System Version 11...
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The first committee draft of the second edition of “IEC 62304 Medical device software life cycle processes” has been circulated internally for comment. Major changes include a revision of how software safety class is determined, which could reduce the tendency towards most software being Class C; clear requirements for legacy software that explain how conformance...
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Company:Elekta, Inc. Date of Enforcement Report 10/31/12 Class ll: PRODUCT Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation treatments in their dimension for the purpose of treating patients with cancer. Recall Number Z-0118-2013 REASON During the planning process the beam weights can be changed by the customers. When the...
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Company: GE Healthcare, LLC Date of Enforcement Report 10/31/12 Class ll: PRODUCT GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1: Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of...
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Company:Orthosensor Date of Enforcement Report 10/31/12 Class ll: PRODUCT ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass Corporate Pkwy***4Th floor***Sunrise, FL 33323***www.orthosensor.com***” Rx Only*** Sterile/EO***Made exclusively for Stryker Orthopaedics***. Is the graphic user interface software associated with the graphic user interface, which is loaded onto the linkstations.Recall Number Z-0122-2013 REASON Ortho sensor in Sunrise, FL...
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Company:GE Healthcare LLC. Date of Enforcement Report 10/31/12 Class ll: PRODUCT GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 A medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. Recall Number Z-0125-2013 REASON GE Healthcare has recently...
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Company:Hospira Inc. Date of Enforcement Report 10/26/12 Class l: PRODUCT Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; List Number 16026-01 Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes,...
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Company:Hospira Inc. Date of Enforcement Report 10/26/12 Class l: PRODUCT Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; List Number 16027-01 Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes,...
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Company:Beckman Coulter Inc. Date of Enforcement Report 10/24/12 Class ll: PRODUCT AutoMate 1250 and AutoMate 2550, Part Numbers ODL25125 and ODL25255. The AutoMate 1200/2500 System Series is a semi-open, pre- and post-analytical sample processing and sorting system. The base system automates the sample sorting, decapping, and archiving processes. Handling and sorting of samples includes automatic...
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Company:Beckman Coulter Inc. Date of Enforcement Report 10/17/12 Class ll: PRODUCT CYTO-STAT tetraCHROME CD45- FITC/CD56-RD1/CD19-ECD/CD3-PC5, Part Number 6607073. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide...
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Company:Beckman Coulter Inc. Date of Enforcement Report 10/17/12 Class ll: PRODUCT CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the...
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A new version of EN 14971 was published and harmonized in the Official Journal of the EU. ISO 14971 now may not ensure compliance with EU essential requirements for medical devices. Specifically, 14971 allows the manufacturer to disregard negligible risks; but all risks must be taken into account and reduced as much as possible to...
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Company:Sunquest Information Systems, Inc. Date of Enforcement Report 10/17/12 Class ll: PRODUCT Sunquest Laboratory. Sunquest Application Interfacing Outbound Department of Health Interface. Recall Number B-2584-12 REASON Software, with a defect or glitch, was distributed. RECALLING FIRM/MANUFACTURER Sunquest Information Systems, Inc., Tuscon, AZ on 12/14/2009. Voluntary: Firm Initiated recall was terminated. VOLUME OF PRODUCT IN COMMERCE...
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Company:Beckman Coulter Inc. Date of Enforcement Report 10/17/12 Class ll: PRODUCT TetraCXP Software System, Part Number A40051. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the...
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See the attached press release from AAMI and UL regarding their collaboration to produce a series of interoperability standards. AAMI UL Interoperability Press Release
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/Docs/scpred/standardsnavigator/GAO_FDA_security_report.pdf
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An FCC mHealth task force reported recommendations to government and industry to address barriers to rapid mHealth deployment. See the link provided: FCC 2012 Mhealth Taskforce Recommendations.
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Draft of the revised IVDD is at the link provided. EU Proposed New IVD
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Draft of the revised MDD is at the link provided. The existing Active Implantable Device Directive is incorporated into the new MDD. EU Proposed New MDD
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Presentations made at the AAMI/FDA Interoperability Summit on October 1-2, 2012, can be found at the link provided. http://www.aami.org/interoperability/presentations
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Company:Imaging Sciences International, LLC Date of Enforcement Report 9/26/12 Class ll: PRODUCT DEXIS Imaging Suite – catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 Radiological Image Processing System Recall Number Z-2463-2012 REASON A condition can occur during renumbering of the patient database using the DEXCopy feature. When renumbering is being performed using the DEXCopy feature...
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Company:RAYSEARCH LABORATORIES AB Date of Enforcement Report 9/26/12 Class ll: PRODUCT SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka t-RayAutoplan, commercial name (TomoTherapy) SharePlan Intended use: t-RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment planning system, generates a family of individually optimized IMRT...
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AAMI has published “AAMI TIR45: 2012 Guidance on the use of AGILE practices in the development of medical device software.” FDA staff was involved in development of this guidance for compliant use of Agile methods. The document can be ordered from AAMI.org.
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Company:Zoll Medical Corp. Date of Enforcement Report 9/26/12 Class ll: PRODUCT Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product is used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. In addition, the product may be used in synchronized...
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Company:Haag-Streit USA Inc. Date of Enforcement Report 9/26/12 Class ll: PRODUCT Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees...
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Company:Roche Molecular Systems, Inc. Date of Enforcement Report 9/26/12 Class ll: PRODUCT Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The software can be used with a Laboratory Information System. Recall Number Z-2403-2012 REASON When using a Laboratory Information system (LIS) with automated systems utilizing AMPLILINK software v3.2...
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Company:Philips Medical Systems (Cleveland) Inc. Date of Enforcement Report 9/26/12 Class lll: PRODUCT The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole Body Computed Tomography X-ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.Recall...
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IEC 62304 and other emerging standards for Medical Device and HealthIT Software

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