Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported November 15, 2017
North Star Imaging Inc. (NSI) Model X-7000 industrial cabinet x-ray system. Industrial x-ray imaging of product hardware
It was discovered a low-level radiation leak that was found on the NSI X-7000 system.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
North Star Imaging Inc recalled North Star Imaging Inc. (NSI) Model X-7000 industrial cabinet x-ray system. Industr… - a moderate-severity action.
North Star Imaging Inc. (NSI) Model X-7000 industrial cabinet x-ray system. Industr… was recalled by North Star Imaging Inc in November 15, 2017. Reason: It was discovered a low-level radiation leak that was found on the NSI X-7000 system.. Check the official notice for the remedy. Verify recall #Z-0063-2018 with the FDA Devices before acting.
The recall
North Star Imaging Inc issued this moderate-severity FDA Devices recall-It was discovered a low-level radiation leak that was found on the NSI X-7000 system..
- Moderate
- severity level
- Class II
- classification
- November 15, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0063-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0063-2018) was formally reported on November 15, 2017, with the manufacturer initiating the action on August 23, 2017. It is classified under Moderate severity (Class II), with a current status of Ongoing. North Star Imaging Inc is listed as the recalling firm, operating out of ROGERS, MN. Federal records list the affected scope as US - 3 units.
The documented reason for this recall is: It was discovered a low-level radiation leak that was found on the NSI X-7000 system. Distribution data in the federal record shows the product reached: US Distribution to the states of : PA, OH and KS.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
US - 3 units
Related Recalls
6
0 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0063-2018 |
| Date reported | November 15, 2017 |
| Date initiated | August 23, 2017 |
| Recalling firm | North Star Imaging Inc |
| Firm location | ROGERS, MN |
| Affected scope | US - 3 units |
| Distribution | US Distribution to the states of : PA, OH and KS. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0063-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
North Star Imaging Inc. (NSI) Model X-7000 industrial cabinet x-ray system. Industrial x-ray imaging of product hardware. Recalled by North Star Imaging Inc. Units affected: US - 3 units.
Why was this product recalled? ▼
It was discovered a low-level radiation leak that was found on the NSI X-7000 system.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 15, 2017. Severity: Moderate. Recall number: Z-0063-2018.
Where was the recalled product distributed? ▼
Distribution: US Distribution to the states of : PA, OH and KS..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0063-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 15, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.