31
Oct
2001

Inc ClassII Marconi Medical Systems

0

Company: Marconi Medical Systems, Inc
Class: II
Date of Enforcement Report: 10/31/01

RECALL NUMBER, PRODUCT AND CODE:
Z-0181-2, Marconi MX8000 Computed Tomography X-ray System, Codes: All
Marconi MX8000 CT Scanners, running with Version 2.0 and 2.01 software.

REASON:
Software in version 2.0 / 2.01 software may lead to improper patient treatment.

MANUFACTURER/RECALLING FIRM:
Marconi Medical Systems, Inc., Highland Heights, OH

RECALLED BY:
The firm, by letter dated 11/7/2000

FIRM INITIATED RECALL:
Complete

DISTRIBUTION:
Nationwide and Worldwide

QUANTITY:
150 (76 domestic)

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

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

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