Recall Z-2441-2019 ยท IZL System, X-Ray, Mobile
Fujifilm Medical Systems U.S.A., Inc.
Fujifilm FDR Go Plus mobile X-ray system
| Date | Jul 19, 2019 |
| Status | Terminated |
| Reason | The graphics driver of the FDR Go PLUS might cause the appearance of a Blue Screen of Death (BSoD) |
| Root cause | Software design |
| Action | Fuji Film issued notifications via FedEx standard overnight mail on July 19, 2019 advising of the problem, health risk and action to take: During this field action, you can continue to use your current FDR Go PLUS by following these additional instructions:1. Set the monitor sleep mode to Off. Complete the Field Action Verification Form, and upon receipt FUJIFILM service personnel will contact you to schedule a visit to correct your device.FUJIFILM will correct your affected device(s) by applying a registry file to your current software version, at no cost to you.. Question contact: Field acti |
| Quantity | 174 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080701 | SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION Shimadzu Corp., May 14, 2008 |