The Recall Desk
HighFDA (Devices)·Z-0063-2018·Announced 2017-11-15

North Star Imaging X-7000 Industrial X-Ray System Recalled for Radiation Leak

North Star Imaging is recalling three Model X-7000 industrial cabinet x-ray systems due to a discovered low-level radiation leak.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a radiation leak, which is a risk-of-harm product defect where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

North Star Imaging Inc. is recalling three units of the Model X-7000 industrial cabinet x-ray system. These devices are used for industrial x-ray imaging of product hardware.

The recall was initiated after a low-level radiation leak was discovered on the NSI X-7000 system. The affected units were distributed in the United States to the states of Pennsylvania, Ohio, and Kansas.

Consumers and businesses with these specific units should stop using them and contact North Star Imaging Inc. for further instructions on the recall.

The recalled product

Product
North Star Imaging Inc. (NSI) Model X-7000 industrial cabinet x-ray system. Industrial x-ray imaging of product hardware
Manufacturer
North Star Imaging Inc
Category
Medical Device — Industrial X-Ray
Hazard
Affected units
3

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Model X-7000

Distribution

Distributed in 3 states:

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