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Recall Observatory FDA recall evidence

Device product

American Science & Engineering Inc,Gemini Cabinet X-ray system.

Z-2206-2015

May 22, 2015

Class II

Product summary

Firm
American Science & Engineering, Inc.
Event
Event 71696
Status
Terminated
Classification
Class II
Quantity
125 systems
Official record key
device-enforcement:Z-2206-2015

Official wording

Reason: During factory testing, we discovered that Gemini systems could, in rare circumstances, experience a fault that leads to a state in which X-rays are being produced but the X-ray indicator lights (located on the operator's console and on both ends of the tunnel) are not illuminated.

Code information: Gemini systems

Distribution pattern: Worldwide Distribution - US Distribution to the states of : NY, FL, TN, PA, NJ, DE, ME, TX, CT, MS, NC, MD, MO, VA, DC, NV and GA., and to the countries of : Saudi Arabia, Indonesia, Canada, Netherlands, Hong Kong, Lebanon and Kazakhstan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    During factory testing, we discovered that Gemini systems could, in rare circumstances, experience a fault that leads to a state in which X-rays are being produced but the X-ray indicator lights (located on the operator's console and on both ends of the tunnel) are not illuminated.