Lumisys/Compurad Info system Class II 483 units

Information Management System for Mammography Practices. Recall #Z-187-9.

REASON

The software was manufactured with methods that resulted in defective information being provided to the physician, and therefore, the patients with positive mammograms may not follow-up with a biopsy exam.

CODE

All copies of Mammoworks Version 2.6.

MANUFACTURER

Lumisys, Inc., (formerly Compurad), Tucson, Arizona.

RECALLED BY

Manufacturer, by memorandum April 16, 1998. Firm-initiated field correction complete.

DISTRIBUTION

Nationwide.

QUANTITY

Approximately 483 units were distributed.