Z-0055-05

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

Name: Z-0055-05 Genital Protector Shield used with Fuji Computed Radiography (FCR) system models 5501D and XU/D1. Model: GP344
Creator: Fujifilm Medical System USA, Inc.
Published: 2004-09-30
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2004-09-30 / Terminated

FDA source

Fujifilm Medical System USA, Inc. began a recall of Genital Protector Shield used with Fuji Computed Radiography (FCR) system models 5501D and XU/D1. Model: GP344 on 2004-09-30. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0055-05
Status: Terminated
Initiated: 2004-09-30
Posted: 2004-10-28
Terminated: 2004-12-22
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Genital Protector Shield used with Fuji Computed Radiography (FCR) system models 5501D and XU/D1. Model: GP344
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
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.
FDA root cause: Other
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.
Quantity in commerce: 16
Distribution: CO, CT, NY, MD, MI, MN, NV, UT
Product codes and lots: All lots

Product code MQB

K993861Class IIFuji Computed Radiography Dual Side Reading, Both Side Reading, Fcr 5501D Dual Side ReaderFujifilm Medical System U.S.A., Inc. / cleared 2000-02-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)