American Science & Engineering, Inc. recalls American Science & Engineering Inc,Gemini Cabinet X-ray system.
- Recall date
- May 22, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2206-2015
- FDA classification
- Class II
- Brand / firm
- American Science & Engineering, Inc.
- Sold / distributed
- 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.
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
American Science & Engineering Inc,Gemini Cabinet X-ray system.
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