American Science & Engineering, Inc.: Medical Device Recall in 2015 - (Recall #: Z-2206-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

American Science & Engineering Inc,Gemini Cabinet X-ray system.

Product Classification:

Class II

Date Initiated: May 22, 2015

Date Posted: August 26, 2015

Recall Number: Z-2206-2015

Event ID: 71696

Reason for Recall:

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.

Status: Terminated

Product Quantity: 125 systems

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.

Voluntary or Mandated:

Voluntary: Firm initiated