FDA recall Z-0063-2018

North Star Imaging Inc · Class II · device

Product

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.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2017-08-23
Report date
2017-11-15
Voluntary/Mandated
FDA Mandated
Location
ROGERS, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0063-2018