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U.S. Department of Health and Human Services

Class 2 Device Recall Xray Cabinet Models

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  Class 2 Device Recall Xray Cabinet Models see related information
Date Initiated by Firm August 23, 2017
Create Date November 06, 2017
Recall Status1 Open3, Classified
Recall Number Z-0063-2018
Recall Event ID 78254
Product Classification Cabinet x-ray, industrial - Product Code RCE
Product North Star Imaging Inc. (NSI) Model X-7000 industrial cabinet x-ray system.

Industrial x-ray imaging of product hardware
Code Information Model X-7000
Recalling Firm/
Manufacturer		 North Star Imaging Inc
19875 S Diamond Lake Rd Ste 10
ROGERS MN 55374-4651
For Additional Information Contact
800-635-8392
Manufacturer Reason
for Recall		 It was discovered a low-level radiation leak that was found on the NSI X-7000 system.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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