Recall Z-2590-2021 ยท IZL System, X-Ray, Mobile
GE Healthcare, LLC
AMX Navigate Mobile X-Ray System
| Date | Sep 29, 2021 (initiated Jun 24, 2021) |
| Status | Terminated |
| Reason | An unexpected column motion while attempting to park the column on the AMX Navigate mobile X-ray system. |
| Root cause | Process control |
| Action | On June 24, 2021 the firm contacted the facilities that received the device via email. An AMX Navigate system was provided to 3 healthcare facilities for evaluation under an agreement with GE Healthcare. While at the healthcare facilities, these systems remained under the ownership of GE Healthcare. After one of the healthcare facilities alerted GE Healthcare to a potential issue with its system, GE Healthcare removed the system from the 3 healthcare facilities in order to perform a detailed engineering analysis as part of its root cause investigation. These 3 systems have not been returned to |
| Quantity | 3 units |
| Distribution | Domestic Distribution Only |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K210982 | AMX Navigate Ge Medical Systems, LLC, Apr 28, 2021 |