Marconi Radiation Planning 57 units Class II


AcQ Plan, 3-D Radiation Therapy Treatment Planning System
(software), a software option for the Computed Tomography (CT)
Scanners. Recall #Z-300-0.


Software anomaly causes the isocenter shift to be labeled


All units using the AcQPlan Therapy Planning software version
4.04 are affected.


Marconi Medical Systems, Inc., Highland Heights, Ohio.


Manufacturer, by telephone on December 20, 1999, and by letter
dated December 21, 1999. Firm-initiated recall ongoing.


Georgia, California, Pennsylvania, Florida, Kentucky, Alabama,
Washington state, Hawaii, North Dakota, Mississippi, Missouri,
Illinois, Massachusetts, New York, Ohio, Idaho, Arizona,


57 units were distributed.

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.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:

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