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News
Company:PerMedics, Inc.,.Date of Enforcement Report 6/23//2010 Class ll: PRODUCT Odyssey Intended use: Radiation treatment planning system. Recall # Z-1609-2010 REASON Anomaly 1, Invalid Characters in Patient ID Error: Currently, Odyssey considers a valid ID to be comprised of numbers and/or letters. If a patient ID in a study contains a character other than a letter...
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Company:Mckesson Medical ImagingDate of Enforcement Report 6/15//2010 Class:ll PRODUCT Voiceware clip software update to certain Horizon Medical Imaging Systems. Intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video and associated medical information from various medical imaging systems. Recall # Z-1735-2010 REASON Voice Clip issue: When the user is...
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Company:Abbott Laboratories, IncDate of Enforcement Report 6/15//2010 Class:ll PRODUCT ARCHITECT System Software v5.00 and v5.10, List Number 5F48-22 and 5F48-23; Part Number 7-204717-01 and 7-204717-02 when used with PM Algorithm LLS Brd, part number 7-94255-01 and PM LLS kit, U10 Chip and Ejectors, part number 7-200788-01. The Abbott ARCHITECT System is designed to perform automated:...
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Recipient: OptoviIe, Inc.. Product: RTVue Optical Coherence Tomography (OCT) with the Normative Database (NDB) Date: 6/11/10 Our inspection revealed your device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C....
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Company:GE Healthcare LLC.Date of Enforcement Report 6/9/2010 Class:ll PRODUCT GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 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 diagnosis imaging systems. When interpreted by a trained physician, mammographic...
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Company:GE Healthcare LLC.Date of Enforcement Report 6/2/2010 Class:ll PRODUCT 1) GE Healthcare, Innova 4100 IQ: GE Innova 4100 / 4100 IQ, Cardiovascular Imaging System (The system consists of a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). Recall # Z-1659-2010; 2) GE Healthcare, Innova 3100 IQ: GE Innova 3100...
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Company:Animas Corp.Date of Enforcement Report 5/26//2010 Class:lll PRODUCT One Touch Ping Insulin Pump using ezManager Max diabetes management software. Recall # Z-1560-2010 REASON Software malfunction which disallows users to download, view and print information from their pump (including blood glucose, insulin delivery, carbohydrate and pump events). Additionally, users are unable to customize the built-in food...
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Company:Vital Images, Inc.Date of Enforcement Report 5/26//2010 Class:ll PRODUCT Vitrea 5.1. Vitrea fX 3.0, Vitrea Enterprise Suite 1.2 with the licensing of CT lung or CT Colon. Recall # Z-1600-2010 REASON Vital images, Inc is issuing a recall notice on their medical device software in the use of CT Lung and CT Colon in Vitrea...
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Company:ZOLL Medical Corp.Date of Enforcement Report 5/19//2010 Class:ll PRODUCT ZOLL E Series Defibrillator/Pacemaker/Monitors, BLS Model, with software versions 4.XX, 6.XX and 7.0X. Intended for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. Recall # Z-1547-2010 REASON Device issued Shock Advised message but failed...
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This SoftwareCPR.com newsletter lists items added to the website from Nov 9, 2009 to May 19, 2010 . It serves as an easy reference to find new or updated items that may be of interest to you and provides a full index of SoftwareCPR educational items. You can click on sections of the document and...
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Company:Optovue Inc.Date of Enforcement Report 5/12//2010 Class:ll PRODUCT Optovue RTVue Optical Coherence Tomography (OCT), Model-RT100 with software versions 3.0.x.x and higher. The RTVue is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an...
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CompanyCarefusionDate of Enforcement Report 4/28//2010 Class:ll PRODUCT NicoletOne vEEG System. Recall # Z-1256-2010 REASON CareFusion NeuroCare is voluntarily implementing a field correction to delete certain NicoletOne software protocols, which users may interpret incorrectly when conducting patient evaluations. The field correction involves providing users with instructions for removing the subject protocols and verifying the deletion has...
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/docs/FDAInfusionPumpDraftGuidance-042310-UCM209337.pdf
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Company: Ge Healthcare ItcDate of Enforcement Report 4/21//2010 Class:ll PRODUCT 1) GE Centricity PACS-IW software; The intended use: The Centricity PACS-IW is used to receive 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....
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Company: Baxter Healthcare CorpDate of Enforcement Report 4/21//2010 Class:ll PRODUCT Baxter 1550 Single Patient System Hemodialysis Machines; product codes 5M5538, 5M5538R, 5M5575, 5M5551 and 5M5551R. Recall # Z-1322-2010 REASON Some of the 1550 Hemodialysis Instruments may have replacement circuit boards with incorrect versions of software.. RECALLING FIRM/MANUFACTURER Recalling Firm: Baxter Healthcare Renal Div., Mc Gaw...
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Recipient: 3CPM, Inc.Product: electrogastrogram (EGG) devices Date: 325/10 6. Failure to establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). For example: b. When requested, no evidence that the changes made to the finished device or...
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Company:Picis IncDate of Enforcement Report 4/15//2010 Class:ll PRODUCT CareSuite” – Critical Care Manager, PACU Manager and Anesthesia Manager Software. Recall # Z-1252-2010 REASON Under specific timing of conditions and in configuration with 3rd party infusion pumps, an error within the clinical application causes the manual documentation of clinical orders to be changed to an automatic...
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http://www.massdevice.com/blogs/massdevice/medical-devices-next-hackers-target-list
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Company:Toshiba American Medical Systems Inc.Date of Enforcement Report 3/31//2010 Class:ll PRODUCT 1) Aplio 50; SSA-700A; software version 5.5r002. Recall # Z-1171-2010; 2) Aplio 80; SSA-770A; software version 5.5r002. Z-1172-2010; 3) Xario; SSA-660A; software version 1.0 and later. Recall # Z-1173-2010 REASON Toshiba America Medical System Inc initiated a field corrective action on Aplio 50; SSA-700A;...
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Company:R. O. Golden & Co., IncDate of Enforcement Report 3/24//2010 Class:ll PRODUCT Image Consultant (IC) Software. Recall # Z-1176-2010 REASON Software not validated. RECALLING FIRM/MANUFACTURER Recalling Firm: R. O. Golden & Co., Inc., Elkins Park, PA, by letters on February 5, 2010. Manufacturer: Unique Media, Canton, PA. Firm initiated recall is ongoing. VOLUME OF PRODUCT...
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Company:Haemonetics Software SolutionsDate of Enforcement Report 3/24//2010 Class:ll PRODUCT Surround System software. Recall # B-0737-10 REASON Software, with a defect or glitch, was distributed. RECALLING FIRM/MANUFACTURER Haemonetics Software Solutions, Rosemont, IL, by e-mail on July 25, 2008. Firm initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 35 units DISTRIBUTION DC, FL, HI, IL, IN,...
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Company:Beckman Coulter Inc.Date of Enforcement Report 3/17/2010 Class:l PRODUCT 1) Coulter LH SlideMaker, LH Barcode Specification, LH SM Intended Use, LH Slide and Sample Flow, Part Number 6605633, P/N 4277248, 4277299, and 277299. Intended for use as an optional peripheral to the Beckman Coulter LH 700 Series System. Creates a blood smear on a clean...
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CDRH is immediately recognizing IEC 60601-1, third edition. The announcement was made yesterday morning at the 20th annual AAMI/FDA international standards conference by Carol Herman, director of the standards management staff at CDRH. The center’s acceptance of the standard also includes “all collaterals and particulars,” said Herman. She anticipates CDRH will publish a Federal Register...
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CDRH is immediately recognizing IEC 60601-1, third edition. The announcement was made yesterday morning at the 20th annual AAMI/FDA international standards conference by Carol Herman, director of the standards management staff at CDRH. The center’s acceptance of the standard also includes “all collaterals and particulars,” said Herman. She anticipates CDRH will publish a Federal Register...
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Attached is a .pdf of a draft guidance from the Chinese medical device regulatory agency (SFDA) that was sent out for comment. SoftwareCPR reviewed and provided a number of comments. It is one of a number of actions by the SFDA indicating movement to more active regulation of medical devices and the software they contain....
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Attached is a pdf of the testimony of FDA’s Director of CDRH Jeff Shuren regarding Health Information Technology Policy. It discusses the need for active regulation FDA regulation, the possible approaches to regulation, and the regulatory basis for this. The Appendix provides some examples of adverse events associated with such systems. It identifies four categories:...
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Company:Baxter Healthcare Corporation.Date of Enforcement Report 3/4/2010 Class:l PRODUCT Baxter Healthcare Corporation, HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems. These systems have been distributed since 1990 REASON Baxter is conducting a recall of the HomeChoice and HomeChoice PRO because of reports of serious injuries and at least one death associated with increased Intraperitoneal Volume...
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Company:Cybernet Systems CorpDate of Enforcement Report 3/3/2010 Class:ll PRODUCT 1) Cybernet Medical MedStar Telemedicine System; Model 533-210. The device is for a remote medical data collection device for the monitoring of patients by healthcare providers. It is intended to work with a weight scale, spirometer, blood pressure unit and pulse oximeter and to transmit data...
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Company:Remel, Inc.Date of Enforcement Report 3/3//2010 Class:ll PRODUCT ERIC (Electronic RapID Compendium) Version 1.0.77, Catalog Number R8323600, used in conjunction with: remel RapID Yeast Plus System is a qualitative micromethod employing conventional and chromogenic substrates for the identification of medically important yeast, yeast-like, and related organisms isolated from human clinical specimens. A complete listing of...
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Company:Sendx Medical IncDate of Enforcement Report 2/17/2010 Class:ll PRODUCT ABL 80 CO-OX System, software versions 1.30 and 1.31 Additional Product Codes: CEM, CGA, CGZ, GHS, GKR, GLY, JFP, JGS, JIX, JJY, JPI The ABL 80 CO-OX System is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The...
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Company:Stryker ImagingDate of Enforcement Report 2/17/2010 Class:ll PRODUCT Stryker Imaging, Guardian Services Software, Part Number 0240-009-430 with Part Numbers 0240-020-013 and 0240-020-022 (Office PACS Power). Intended use is to act as a medical data backup and disaster recovery plan. Recall # Z-0134-2010 REASON Firm has determined Guardian Services does not contain 100% data backup for...
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Company:GE Medical SystemsDate of Enforcement Report 2/3/2010 Class:ll PRODUCT GE Healthcare MAC 800 RESTING ECG ANALYSIS SYSTEM. The MAC 800 is a portable EGG acquisition, analysis and recording system. The MAC 800 is intended to acquire, analyze, display and record information from adult and pediatric populations. Pediatric population is defined as patients between the ages...
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On February 20, 2003, a final security rule 45 CFR Part 142 was issued. Subsequently HHS issued a series of educational documents regarding various aspects of the rule including administrative controls, physical controls, technical safeguards, risk management and others.  
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Company:GE HealthcareDate of Enforcement Report 2/3/2010 Class:ll PRODUCT 1) GE OEC 9900 Elite ESP, to produce mobile fluoroscopic images of human anatomy. Recall # Z-0004-2010; 2) GE OEC 9900 Elite GSP Fluoroscopes To produce mobile fluoroscopic images of human anatomy. Recall # Z-0005-2010 REASON A software defect – may result in a false indication and...
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Company:GE HealthcareDate of Enforcement Report 2/3/2010 Class:ll PRODUCT 1) iDXA, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2,13.0, & 13.1. The systems provide an estimate of BMD. Recall # Z-0600-2010; 2) Prodigy 1-8 series, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2, 13.0, & 13.1....
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Company:Edwards Lifesciences Inc.br>Date of Enforcement Report 1/11/2010 Class:l PRODUCT Edwards Lifesciences “Aquarius” System; Model Numbers: GEF08200, GEF09500, GEF09600, GEF09700, and GEF09800, using Software version 6.00.04. The Aquarius monitors the fluid going into and coming out of the patient. Recall # Z-0653-2010 This product was manufactured from July 12, 2007 through March 18, 2009 and distributed...
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Company:Hocoma AG,br>Date of Enforcement Report 1/27/2010 Class:ll PRODUCT Hocoma Lokomat-System with Pediatric Module Software Versions: V4.30, V4.31, V4.31a, V4.31b, V4.31c, V4.32, V4.32a, V5.0x. Powered exercise equipment used to apply automated locomoter training for hemiplegic and paraplegic patients. Recall # Z-0590-2010 REASON Changes to the stored “sensitivity” values may occur and leads to higher limits in...
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Company:Philips Healthcare IncDate of Enforcement Report 1/27/2010 Class:ll PRODUCT 1) SureSigns Patient Monitors (VM3, VM4. VM6. VM8): VM3 3/5 lead ECG/SPo2, Respiration Bedside Patient Monitor with 8.4″display VM4 3 Lead ECG, NBP, SPo2, optional Predictive Temp Bedside Patient Monitor with 8.4″ display VM6 3/5 Lead ECG, NBP, Temp, optional SPo2 Bedside Patient Monitor with 8.4″...
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Company:Smiths Medical.ASD Inc.Date of Enforcement Report 1/20/2010 Class:ll PRODUCT 1) Smiths Medical Medfusion model 3500 syringe Infusion pump, software version V3.0.6. Model 3500. Rx Only. Recall # Z-0650-2010; 2) Smiths Medical Medfusion model 3010a syringe Infusion pump. REF 3010A. Rx Only. Recall # Z-0651-2010 REASON Smiths Medical has become aware of an increased trend in...
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Company:General Electric Medical Systems Information TechnologyDate of Enforcement Report 1/20/2010 Class:ll PRODUCT GE ApexPro Oximeter systems (ApexPro CH or ApexPro FH with ApexPro Telemetry version 3.9 software). Recall # Z-0631-2010 REASON Potential misuse of the ApexPro Telemetry System and incorrect message and alarm information in the ApexPro Operator’s Manual may impact patient safety. When ApexPro...
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Company:GE Medical Systems, LLCDate of Enforcement Report 1/13/2010 Class:ll PRODUCT GE Healthcare Voluson E6, GE Voluson E8, and GE Voluson E8 Expert Diagnostic Ultrasound Systems. Recall # Z-0541-2010 REASON GE Healthcare has recently become aware of an incorrect operating procedure associated with software versions 9.0.0, 9.0.1, and 9.0.2 of the Voluson E6 or Voluson E8...
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Company: Sunrise Pharmaceutical, Inc Date: 1/14/10 Product: Pharmaceuticals Your firm has not exercised appropriate controls over computer or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel [21 CFR 211.68(b)]. For example, your firm lacks systems to ensure that all electronic data generated...
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The link provided is for “42 CFR Parts 412, et al. Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule.” 42CFR_412_EHR_HITECH
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At the link provided is a paper issued in April 2008 by the Australian Department of Defense entitled: “Dependability of Software in Airborne Mission Systems”. It contains a useful list and description of software related standards outside the medical device industry that may be helpful in medical device software development and risk management. AUS SW...
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SoftwareCPR Training Courses:

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 onsite with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

Next public offering:  June 24-26, 2025 (Boston, MA)

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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
  • Backlog management
  • Agile risk management
  • Incremental and iterative software development lifecycle management
  •  Frequent release management
  • And more!

3 days virtual (Zoom) with group exercises, quizzes, examples, Q&A.

Lead Instructor: Mike Russell

Next public offerings:

  • Americas: 11-13 February 2025
  • EU/Eastern Europe/Middle East/Africa/Atlantic/eastern South America: 18-20 February 2025
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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.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

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