19
Apr
2006

Class II Fischer Imaging Corporation

0

Company:Fischer Imaging Corporation,
Date of Enforcement Report:4/19/2006
Class:lI

PRODUCT
SenoScan Full Field Digital Mammography System, Product number 94001G-3, 105200G, Recall # Z-0757-06

REASON
Software upgrade to preclude lost images during mammography procedure.

CODE
Software versions earlier than 5.2.2

RECALLING FIRM/MANUFACTURER
Fischer Imaging Corporation, Denver, CO, by letter on March 27, 2006, firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
80 units ,p>
DISTRIBUTION
Nationwide

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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