Recall Z-3036-2017 ยท KPR System, X-Ray, Stationary
NeuroLogica Corporation
Samsung GU60A system- Digital X-ray Imaging Systems are 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 24, 2017 |
| Status | Terminated |
| Reason | When performing the Stitching function on GU60A system, unintended area is exposed to radiation |
| Root cause | Device Design |
| Action | Neurologica will bring defect into compliance : 1.All facilities were notified via a customer notification letter. 2.Samsung will release improved software to avoid unintended exposure. When setting the stitching area, if there is an over exposed area, the height of the swivel arm will be lowered over the exposed area and the first region (first image) will be collimated by the bottom blade. 3.A software patch was developed: SW3.01 was released on 05/08/2017 and SW1.00 was released on 07/28/17. 4.The software patch will be installed on the affected devices. 5.Samsung has provided the |
| Quantity | 87 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.