Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 26, 2015
American Science & Engineering Inc,Gemini Cabinet X-ray system.
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 i…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
American Science & Engineering, Inc. recalled American Science & Engineering Inc,Gemini Cabinet X-ray system. - a moderate-severity action.
American Science & Engineering Inc,Gemini Cabinet X-ray system. was recalled by American Science & Engineering, Inc. in August 26, 2015. Reason: During factory testing, we discovered that Gemini systems could, in rare circumstances, experience a fault th…. Check the official notice for the remedy. Verify recall #Z-2206-2015 with the FDA Devices before acting.
The recall
American Science & Engineering, Inc. issued this moderate-severity FDA Devices recall-During factory testing, we discovered that Gemini systems could, in rare circumstances, experience a fault th….
- Moderate
- severity level
- Class II
- classification
- August 26, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2206-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2206-2015) was formally reported on August 26, 2015, with the manufacturer initiating the action on May 22, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. American Science & Engineering, Inc. is listed as the recalling firm, operating out of Billerica, MA. Federal records list the affected scope as 125 systems.
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: 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, Leba…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
125 systems
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2206-2015 |
| Date reported | August 26, 2015 |
| Date initiated | May 22, 2015 |
| Recalling firm | American Science & Engineering, Inc. |
| Firm location | Billerica, MA |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2206-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
American Science & Engineering Inc,Gemini Cabinet X-ray system.. Recalled by American Science & Engineering, Inc.. Units affected: 125 systems.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 26, 2015. Severity: Moderate. Recall number: Z-2206-2015.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2206-2015) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 26, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.