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Terminated

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

FDA Recall Z-2206-2015 · Posted 2015-08-14

Recalling FirmAmerican Science & Engineering, Inc.
Recall StatusTerminated
Product CodeRCG
Date Initiated2015-05-22
Date Terminated2017-02-22
Product Quantity125 systems

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.

Firm Action

American Science Engineering, Inc (AS&E) is developing a fix for this problem that includes updating a software configuration on the X-ray source. You will be notified by field service as soon as this update is available. Please inform all operators of the system about this communication, so they are aware of the need to shut down and re-start the system should this fault occur. We appreciate your understanding. if you have any questions, please feel free to contact AS&E via e-mail at [email protected]. If you are under a service contract, you can also contact your customer service representative. For further questions please call (978) 262-8700.

Root Cause

Vendor change control

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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