Recall Z-0055-05 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Fujifilm Medical System USA, Inc.
Genital Protector Shield used with Fuji Computed Radiography (FCR) system models 5501D and XU/D1. Model: GP344
| Date | Oct 28, 2004 (initiated Sep 30, 2004) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993861 | FUJI COMPUTED RADIOGRAPHY DUAL SIDE READING, BOTH SIDE READING, FCR 5501D DUAL SIDE READER Fujifilm Medical System U.S.A., Inc., Feb 10, 2000 |