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Terminated

Fuji Flash IIP and CR-IR346CL Consoles

FDA Recall Z-0993-04 · Posted 2004-07-20

Recalling FirmFujifilm Medical System USA, Inc.
Recall StatusTerminated
Product CodeMQB
Date Initiated2004-05-05
Date Terminated2005-04-20
Product Quantity2602 units

Reason for Recall

Software: Incorrect measurement of objects within a CR image

Firm Action

FujiFilm Medical Systems issued notification letter dated 5/5/04 via Certified Mail. Units will be field corrected with a revised software by a service representative.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K013218FUJI SPEED SUITE, FUJI SPEED SUTE PHASE IIFujifilm Medical System U.S.A., Inc. · 2001-12-20

Official Source

View FDA Recall →

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

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