Medical device recalls Moderate risk

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.

Get recall alerts

Free email alert whenever American Science & Engineering, Inc. has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: American Science & Engineering, Inc.