Recall Z-0063-2018 ยท RCE Cabinet X-Ray, Industrial
North Star Imaging Inc
North Star Imaging Inc. (NSI) Model X-7000 industrial cabinet x-ray system. Industrial x-ray imaging of product hardware
| Date | Aug 23, 2017 |
| Status | Open, Classified |
| Reason | It was discovered a low-level radiation leak that was found on the NSI X-7000 system. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | North Star Imaging will bring defect into compliance by the following : The Center for Devices and Radiological Health (CDRH) understands that the CAP involving 3 units will consist of the following: 1. All three customers have been notified that the affected products will be repaired free of charge. 2 .The area where the emission rate could be exceeded will have shielding added until emissions are adequately attenuated under the conditions described above. 3. The repaired systems will be completely surveyed to verify compliance with the cabinet x- ray system performance standard |
| Quantity | US - 3 units |
| Distribution | US Distribution to the states of : PA, OH and KS. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.