American Science & Engineering Inc — Class II medical device recall Z-2206-2015
Terminated recall by American Science & Engineering, Inc., reported 2015-08-26, distributed in CT, DC, DE, FL, GA, MD, ME, MO…. During factory testing, we discovered that Gemini systems could, in rare circumstances, experience a fault tha
| Recall number | Z-2206-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Science & Engineering, Inc., Billerica, MA, United States |
| Recall initiated | 2015-05-22 |
| Classified | 2015-08-14 |
| Reported by FDA | 2015-08-26 |
| Terminated | 2017-02-22 |
| Distributed | CT, DC, DE, FL, GA, MD, ME, MO, MS, NC, NJ, NV, NY, PA, TN, TX, VA |
| Countries outside the US | CA, HK, ID, LB, NL, SA |
| Quantity | 125 systems |
Product
American Science & Engineering Inc,Gemini Cabinet X-ray system.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2206-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.