CSI Spectroscopy Class II

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.

FDA and 62304 Training – Boston – June 4-6, 2019

3-day course is designed to gain an understanding of how 62304 and other standards can be implemented efficiently and effectively while meeting FDA expectations as well.  John F. Murray, Jr., will be among the faculty!
The discounted April registration expires on April 30, 2019, or when all discounted seats are sold.

Corporate Office

+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TN) and Italy.