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.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

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