FDA Medical Device Recalls (openFDA)
American Science & Engineering, Inc.: American Science & Engineering Inc,Gemini Cabinet X-ray system.
- Recall number
- Z-2206-2015
- Recalling firm
- American Science & Engineering, Inc.
- Product
- American Science & Engineering Inc,Gemini Cabinet X-ray system.
- Status
- Terminated
- Initiated
- 2015-05-22
- Posted
- 2015-08-14
- Terminated
- 2017-02-22
- Reason
- 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
- 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 service@as-e.com. If you are under a service contract, you can also contact your customer service representative. For further questions please call (978) 262-8700.
- Quantity
- 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.
- Lot, serial or model codes
- Gemini systems
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- RCG
- Firm FEI
- 1215713
- Firm city
- Billerica
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28