25
Aug
2011

Cl ll Monaco Radiation Treatment Planning Worksta

0

Company: Computerized Medical Systems Inc.
Date of Enforcement Report 8/24/11
Class ll:

PRODUCT
Monaco Radiation Treatment Planning Workstation. Monaco Release 2.04.00 and above. Used to create treatment plans for any cancer patient for who external beam intensity modulated radiation therapy (IMRT) has been prescribed. Recall # Z-2569-2011

REASON
Monaco: In XiO IMRT (Dynamic MLC Delivery) software, the radiation beam angle is set to zero. If different beam angles are selected via Monaco software, the beam angles will remain at zero.

RECALLING FIRM/MANUFACTURER
Computerized Medical Systems Inc., Maryland Heights, MO, by letter on October 27, 2010. FDA initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
11 units

DISTRIBUTION
Nationwide and the Netherlands

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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

Instructor: Brian Pate

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

Lead Instructor: Mike Russell

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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)

Next public offering:  TBD

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