Z-0063-2018Class II

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

Name: Z-0063-2018 North Star Imaging Inc. (NSI) Model X-7000 industrial cabinet x-ray system. Industrial x-ray imaging of...
Creator: North Star Imaging Inc
Published: 2017-08-23
License: https://open.fda.gov/license/

North Star Imaging Inc / initiated 2017-08-23 / Open, Classified

FDA source

North Star Imaging Inc began a recall of North Star Imaging Inc. (NSI) Model X-7000 industrial cabinet x-ray system. Industrial x-ray imaging of product hardware on 2017-08-23. FDA classified it as Class II and gives the reason as "It was discovered a low-level radiation leak that was found on the NSI X-7000 system". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0063-2018
Classification: Class II
Status: Open, Classified
Initiated: 2017-08-23
Posted: 2017-11-06
Recalling firm: North Star Imaging Inc
Product: North Star Imaging Inc. (NSI) Model X-7000 industrial cabinet x-ray system. Industrial x-ray imaging of product hardware
Product code: RCE Cabinet X-Ray, Industrial
Reason for recall: It was discovered a low-level radiation leak that was found on the NSI X-7000 system.
FDA root cause: Radiation Control for Health and Safety Act
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.
Quantity in commerce: US - 3 units
Distribution: US Distribution to the states of : PA, OH and KS.
Product codes and lots: Model X-7000

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0063-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0063-2018	Class II	Ongoing	FDA Mandated	2017-11-15	2017-11-06

Product code RCE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)