North Star Imaging Inc. (NSI) Model X-7000 industrial cabinet x-ray system. Industrial x-ray imaging of product hardware
- Company
- North Star Imaging Inc
- Recall Initiated
- August 23, 2017
- Recall Number
- Z-0063-2018
- Quantity
- US - 3 units
- Firm Location
- ROGERS, MN
Reason for Recall
It was discovered a low-level radiation leak that was found on the NSI X-7000 system.
Distribution
US Distribution to the states of : PA, OH and KS.
Lot / Code Info
Model X-7000
Root Cause
Radiation Control for Health and Safety Act
Action Taken
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 standards emission limit. 4.All repairs will be completed before February 1, 2018. For further questions, please call (800) 635-8392.