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.

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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