CLASS II ONGOING Device recall · Reported 15 Nov 2017 · FDA Enforcement Report
North Star Imaging Inc. (NSI) Model X-7000 industrial cabinet x-ray recalled
North Star Imaging is recalling North Star Imaging Inc. (NSI), distributed in Kansas, Ohio, Pennsylvania. The recall was initiated on 23 Aug 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0063-2018
- FDA event ID
- 78254
- Recalling firm
- North Star Imaging, ROGERS, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Aug 2017
- FDA classified
- 6 Nov 2017
- Reported
- 15 Nov 2017
- Type
- FDA Mandated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Imaging Equipment
Timeline
| 23 Aug 2017 | Recall initiated by company | |
| 6 Nov 2017 | Classified by FDA | +75 days |
| 15 Nov 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
It was discovered a low-level radiation leak that was found on the NSI X-7000 system.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
North Star Imaging Inc. (NSI) Model X-7000 industrial cabinet x-ray system. Industrial x-ray imaging of product hardware
Where it was distributed
US Distribution to the states of : PA, OH and KS.
Questions about this recall
Is North Star Imaging Inc. (NSI) Model X-7000 industrial cabinet x-ray recalled?
Yes. North Star Imaging recalled North Star Imaging Inc. (NSI) Model X-7000 industrial cabinet x-ray on 23 Aug 2017. The recall is Class II and its status is Ongoing. Recall number Z-0063-2018.
Why was it recalled?
It was discovered a low-level radiation leak that was found on the NSI X-7000 system.
Which lots are affected?
Model X-7000
Where was it sold?
US Distribution to the states of : PA, OH and KS.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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