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Terminated

Genital Protector Shield used with Fuji Computed Radiography (FCR) system models 5501D and XU/D1. Model: GP344

FDA Recall Z-0055-05 · Posted 2004-10-28

Recalling FirmFujifilm Medical System USA, Inc.
Recall StatusTerminated
Product CodeMQB
Date Initiated2004-09-30
Date Terminated2004-12-22
Product Quantity16

Reason for Recall

Genital Protector Shield used with Fuji Computed Radiography (FCR) system models 5501D and XU/D1. Model: GP344 may detach from the mounting block and fall during use.

Firm Action

Fuji are notifying users through Fuji service representatives who are hand delivering the notfication letter dated 9/30/04 and installing the mandatory hardware upgrade.

Root Cause

Other

Distribution Pattern

CO, CT, NY, MD, MI, MN, NV, UT

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K993861FUJI COMPUTED RADIOGRAPHY DUAL SIDE READING, BOTH SIDE READING, FCR 5501D DUAL SIDE READERFujifilm Medical System U.S.A., Inc. · 2000-02-10

Official Source

View FDA Recall →

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

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