Z-2206-2015Class II

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

Name: Z-2206-2015 American Science & Engineering Inc,Gemini Cabinet X-ray system
Creator: American Science & Engineering, Inc.
Published: 2015-05-22
License: https://open.fda.gov/license/

American Science and Engineering, Inc. / initiated 2015-05-22 / Terminated / root cause: supplier

FDA source

American Science & Engineering, Inc. began a recall of American Science & Engineering Inc,Gemini Cabinet X-ray system on 2015-05-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-2206-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-22
Posted: 2015-08-14
Terminated: 2017-02-22
Recalling firm: American Science and Engineering, Inc.
Product: American Science & Engineering Inc,Gemini Cabinet X-ray system.
Product code: RCG Cabinet X-Ray, Security (Includes Baggage X-Ray)
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.
Root cause tag: supplier
FDA root cause: Vendor change control
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.
Quantity in commerce: 125 systems
Distribution: 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.
Product codes and lots: Gemini systems

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2206-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2206-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-14

Product code RCG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)