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Terminated

Fischer SenoScan True View Digital Mammography System.

FDA Recall Z-1094-04 · Posted 2004-07-20

Recalling FirmFischer Imaging Corporation
Recall StatusTerminated
Product CodeMUE
Date Initiated2004-05-21
Date Terminated2004-07-16
Product Quantity12 units

Reason for Recall

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

Firm Action

Customers were notified by phone and certified letter on 05/21/2004.

Root Cause

Other

Distribution Pattern

FL, NC, NY, OK, WI. Foreign distribution to France.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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