Z-0063-2018 Class II Ongoing
FDA device recall Z-0063-2018 was initiated by North Star Imaging Inc on August 23, 2017 and is designated Class II. Reason for recall: It was discovered a low-level radiation leak that was found on the NSI X-7000 system. The recall status is ongoing. Affected quantity: US - 3 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 15, 2017
- Initiation Date
- August 23, 2017
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- US - 3 units
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.
Distribution Pattern
US Distribution to the states of : PA, OH and KS.
Code Information
Model X-7000