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Terminated

Synapse Version 2.2.1 and 2.3.1 software

FDA Recall Z-0932-03 · Posted 2003-06-12

Recalling FirmFujifilm Medical System USA, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2003-05-12
Date Terminated2004-05-25
Product Quantity54 units

Reason for Recall

Synapse Version 2.2.1 and 2.3.1 Software [Free-Hand Region] may lead to incorrect density calculations during CT scan

Firm Action

FujiFilm notified users via letter notification during the week of May 12, 2003. Users wll be visited by a Regional Service Engineer to install the corrected software.

Root Cause

Other

Distribution Pattern

Nationwide Foreign: Canada, Germany, Israel, Japan

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K991257FUJI WAVELET COMPRESSION OR FFCOMP IRREVERSIBLE COMPRESSIONFujifilm Medical System U.S.A., Inc. · 1999-06-25

Official Source

View FDA Recall →

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

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