Recall Z-1691-2019 ยท IZL System, X-Ray, Mobile
NeuroLogica Corporation
Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications
| Date | May 6, 2019 |
| Status | Terminated |
| Reason | Potential issue related to the operation of the safety latch within the column that supports the arm due to a possibility of potential bodily harm due to a fall of the arm in an unlikely event that the column wire breaks. |
| Root cause | Process control |
| Action | NeuroLogica Corporation, a subsidiary of Samsung Electronics issued Medical Device Correction Notice on 05/06/19 advising users of the problem, health risk and action to take: Service engineers will correct all affected devices free of charge and contact you to arrange for the correction. All corrections in the field will be completed by September, 2019. Users may continue to use the GM85 system. This notice needs to be passed on all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred.If you need any further in |
| Quantity | 288 systems |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171119 | GM85 Samsung Electronics Co., Ltd., May 12, 2017 |