Day

December 8, 2010
Company:Volcano Corp., Date of Enforcement Report 12/8/2010 Class ll: PRODUCT Volcano s5/s5i imaging system Family Software version 3.2, Part Numbers 435-0602.01 to 05, including ChromaFlo and Virtual Histology. Recall # Z-0168-2011 REASON Software defect results in improper image brightness, which may result in introduction of artifacts, which may cause misclassification of results and affect classification...
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Company: Hospira, Inc.Date of Enforcement Report: 12/8/2010 Class ll: PRODUCT EndoTool Drug Dose Calculator-Software Version 7.2.1800.3 and 7.2.1825.5. Recall # Z-0126-2011 REASON The EndoTool software did not always provide an audible alert when a blood glucose measurement was due. This could result in a patient not receiving an appropriate dose of insulin. RECALLING FIRM/MANUFACTURER Recalling...
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Company: Philips Healthcare.Date of Enforcement Report 12/8/2010 Class ll: PRODUCT Computed Tomography X-Ray System MX 8000 IDT 16; Model # 728120; Produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. Recall # Z-0133-2011 REASON Philips Healthcare has decided to recall the Computed Tomography X-Ray System...
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Company:Philips Medical Systems Date of Enforcement Report 12/8/2010 Class ll: PRODUCT 1) Allura Xper FD10 Monoplane X-ray system. Intended for use in cardiovascular and vascular x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA and stent placement and atherectomies), pacemaker implantations and electrophysiology. It is compatible with specified magnetic navigation systems. Recall # Z-0124-2011;...
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Company: CareFusion Corp..Date of Enforcement Report 12/8/2010 Class ll: PRODUCT Alaris PC unit Model 8000 only when used with Alaris Pump module or Alaris Syringe module. Recall # Z-0492-2011 REASON Issue: PC Unit model 8000, when used with Pump or Syringe modules, may under certain conditions display an incorrect total dose when programmed to deliver...
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Company:Instrumentation Laboratory Co.Date of Enforcement Report 12/8/2010 Class ll: PRODUCT 1) ACL TOP (Base) PN 000280000 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis...
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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:  TBD

Email training@softwarecpr.com to request a special pre-registration discount.  Limited number of pre-registration coupons.

Registration Link:

TBD

 


 

Being Agile & Yet Compliant (Public or Private)

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

  • Agile principles that align well with medical
  • Backlog management
  • Agile risk management
  • Incremental and iterative software development lifecycle management
  •  Frequent release management
  • And more!

2-days onsite (4 days virtual) with group exercises, quizzes, examples, Q&A.

Instructors: Mike Russell, Ron Baerg

Next public offering: March 7 & 28, 2024

Virtual via Zoom

Registration Link:

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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)

Next public offering:  TBD

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