Genital Protector Shield used with Fuji Computed Radiography (FCR) system models 5501D and XU/D1. Model: GP344
FDA device recall Z-0055-05 · posted 2004-10-28 · Terminated
Recall details
- Recalling firm
- Fujifilm Medical System USA, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 16
- Distribution
- CO, CT, NY, MD, MI, MN, NV, UT
- Date initiated
- 2004-09-30
- Date posted
- 2004-10-28
- Date terminated
- 2004-12-22
- Location
- Stamford, CT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FUJI COMPUTED RADIOGRAPHY DUAL SIDE READING, BOTH SIDE READING, FCR 5501D DUAL SIDE READER (K993861) | Fujifilm Medical System U.S.A., Inc. | 2000-02-10 |