03
Feb
2000

CSI Spectroscopy Class II

0

REASON

Due to a software anomaly, the device acquires data from a slice thicker than intended, and may not be at isocenter.

PRODUCT
Chemical-Shift Imaging (CSI) Spectroscopy, Model 90LNI.

Recall #Z-412-0.

CODE

Serial Numbers: AF212E, BA109P, BA218P, BA103P, AF165E, AF157EU, BA183P,
BA118P, BA182P, BA164D, BA178P, BA114P, BA225P, BA187P, AF113EU, BB104P,
BA110P, BA131D, and BA192D.

MANUFACTURER

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

RECALLED BY

Manufacturer, by letter dated February 3, 2000. Firm-initiated recall ongoing.

DISTRIBUTION

Florida, Maryland, Massachusetts, Utah, Arizona, Australia, Italy, Germany, Japan, China and England.

QUANTITY

19 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.

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