North Star Imaging Inc. (NSI) Model X-7000 industrial cabinet x-ray system. Industrial x-ray imaging of product hardware
Recall
- Recall Number
- Z-0063-2018
- Event Number
- 78254
- Firm
- North Star Imaging Inc
- FEI Number
- 3009067082
- Product Code
- RCE
- Status
- Open, Classified
- Root Cause
- Radiation Control for Health and Safety Act
- Initiated
- August 23, 2017
- Address
- 19875 S Diamond Lake Rd, Ste 10, ROGERS, MN, 55374-4651
Description
North Star Imaging Inc. (NSI) Model X-7000 industrial cabinet x-ray system. Industrial x-ray imaging of product hardware
It was discovered a low-level radiation leak that was found on the NSI X-7000 system.
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.
US Distribution to the states of : PA, OH and KS.
US - 3 units