24
Oct
2001

Inc Class III Marconi Medical Systems

0

Company: Marconi Medical Systems, Inc
Date of Enforcement Report: 10/24/01
Class: III

RECALL NUMBER, PRODUCT AND CODE:
Z-0057-2, Marconi MX8000 Computed Tomography X-ray
Codes: All Marconi MX8000 CT Scanners running with Version 2.0
sofware.

REASON:
A software anomaly in ver 2.0 software may result in improper patient diagnosis.

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

RECALLED BY:
The firm by letter, dated 8/10/2000

FIRM INITIATED RECALL:
Complete

DISTRIBUTION:
Nationwide and Brazil

QUANTITY:
76

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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