21
Jul
2004

Fischer Imaging Corp Class II

0

Company: Fischer Imaging Corp
Date of Enforcement Report: 7/21/04
Class: II

PRODUCT
Fischer SenoScan True View Digital Mammography System. Recall # Z-1094-04.

REASON
Existing software may allow Image data to be truncated in the margin of the breast on processed patient images.

CODE
Product number 94829G-1, 94830G-1, 94830G-2.

RECALLING FIRM/MANUFACTURER
Fischer Imaging Corp, Denver, CO, by telephone and letter on May 21, 2004. Firm initiated recall is complete.

VOLUME OF PRODUCT IN COMMERCE
12 units.

DISTRIBUTION
FL, NC, NY, OK, WI, and France.

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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