August 26, 2015Medical DevicesFDA
American Science & Engineering, Inc. recalls American Science & Engineering Inc,Gemini Cabinet X-ray system.
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.