FDA Enforcement
Class II
Ongoing
North Star Imaging Inc. (NSI) Model X-7000 industrial cabinet x-ray system. Industrial x-ray imaging of product hardware
Recall: Z-0063-2018
·
Reported November 15, 2017
Enforcement
- Recall Number
- Z-0063-2018
- Event ID
- 78254
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- North Star Imaging Inc
- Voluntary / Mandated
- FDA Mandated
- Initial Notification
- Letter
- Report Date
- November 15, 2017
- Initiation Date
- August 23, 2017
- Classification Date
- November 6, 2017
- Address
- 19875 S Diamond Lake Rd Ste 10, N/A, ROGERS, MN, 55374-4651, United States
Description
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.
Code Info
Model X-7000
Distribution
US Distribution to the states of : PA, OH and KS.
Quantity
US - 3 units