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Open, Classified

North Star Imaging Inc. (NSI) Model X-7000 industrial cabinet x-ray system. Industrial x-ray imaging of product hardware

FDA Recall Z-0063-2018 · Posted None

Recalling FirmNorth Star Imaging Inc
Recall StatusOpen, Classified
Product CodeRCE
Date Initiated2017-08-23
Product QuantityUS - 3 units

Reason for Recall

It was discovered a low-level radiation leak that was found on the NSI X-7000 system.

Firm 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 standards emission limit. 4.All repairs will be completed before February 1, 2018. For further questions, please call (800) 635-8392.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

US Distribution to the states of : PA, OH and KS.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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