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.

Schedule Discussion with John F. Murray, Jr.

John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

Leave a message and we will contact you to schedule:

Corporate Office

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