Recall Z-1414-2023 ยท IZL System, X-Ray, Mobile
NeuroLogica Corporation
Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System
| Date | Apr 19, 2023 (initiated Mar 8, 2023) |
| Status | Open, Classified |
| Reason | Issue related to the operation of the arm latch within the column that supports the arm, potential bodily harm due to a fall of the arm |
| Root cause | Device Design |
| Action | NeuroLogica (Importer)for Samsung Electronics GM85 digital x-ray system issued Urgent Medical Device Correction letter issued 3/8/23 via email. Letter states reason for recall, health risk and action to take: Please identify the system label and confirm whether or not your device is one of those affected by this FSN. The list of affected serial numbers is provided in the Appendix. Samsung Electronics will undertake the voluntary corrective action considering the possibility of potential bodily harm due to the fall of the arm. Service engineers will correct all affected devices free of charge |
| Quantity | 935 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K222353 | GM85 Samsung Electronics Co., Ltd., Sep 29, 2022 |