Device product
American Science & Engineering Inc,Gemini Cabinet X-ray system.
Z-2206-2015
Product summary
- 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
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.