Recall Z-0063-2018— North Star Imaging Inc

Class II · Ongoing

Class II FDA medical device recall by North Star Imaging Inc, initiated 2017-08-23. FDA's recall record names no specific 510(k) clearance for this event. Product: North Star Imaging Inc. (NSI) Model X-7000 industrial cabinet x-ray system. Industrial x-ray imaging of product hardware. Reason: It was discovered a low-level radiation leak that was found on the NSI X-7000 system..

Recalling firm
North Star Imaging Inc
Classification
Class II
Status
Ongoing
Initiated
2017-08-23
Firm location
ROGERS, MN, United States

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.