FDA Medical Device Recalls (openFDA)
Fujifilm Medical System USA, Inc.: Genital Protector Shield used with Fuji Computed Radiography (FCR) system models 5501D and XU/D1. Model: GP344
- Recall number
- Z-0055-05
- Recalling firm
- Fujifilm Medical System USA, Inc.
- Product
- Genital Protector Shield used with Fuji Computed Radiography (FCR) system models 5501D and XU/D1. Model: GP344
- Status
- Terminated
- Initiated
- 2004-09-30
- Posted
- 2004-10-28
- Terminated
- 2004-12-22
- Reason
- 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.
- 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
- 16
- Distribution
- CO, CT, NY, MD, MI, MN, NV, UT
- Lot, serial or model codes
- All lots
- 510(k) numbers
- ["K993861"]
- PMA numbers
- not on file
- Product code
- MQB
- Firm FEI
- 1000513161
- Firm city
- Stamford
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28