FDA-Device2015-08-26Class II
American Science & Engineering Inc,Gemini Cabinet X-ray system.
American Science & Engineering, Inc.
Hazard
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.
Sold states
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.
Affected count
125 systems
Manufactured in
829 Middlesex Tpke, Billerica, MA, United States
Products
American Science & Engineering Inc,Gemini Cabinet X-ray system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2206-2015Don't want to check this manually?
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