Recall Z-0726-2018 ยท KPR System, X-Ray, Stationary
NeuroLogica Corporation
The GC80 Digital X-ray Imaging System
| Date | Jun 22, 2017 |
| Status | Terminated |
| Reason | An image was obtained with over exposure during a Thorax examination using the AEC function. |
| Root cause | Other |
| Action | On June 22, 2017, Samsung distributed Urgent Field Safety Notices & acknowledgment forms to their customers via email. INSTRUCTIONS FOR END USERS: 1) Please read the Field Safety Notice documentation in detail. 2) Follow the instructions provided in this FSN in relation to any actions which are required of you. 3) Complete the provided acknowledgement form and return to your supplier as soon as possible. Your organizations reply is the evidence we need to monitor the progress of the corrective actions. 4) If required and instructed by this FSN documentation, please undertake all relevant s |
| Quantity | 45 units |
| Distribution | Nationwide US |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143029 | Digital Diagnostic X-ray System (GC80) Samsung Electronics Co., Ltd., Feb 4, 2015 |