American Science & Engineering Recalls Gemini Cabinet X-ray Systems
American Science & Engineering is recalling 125 Gemini Cabinet X-ray systems because a fault may cause X-rays to be produced without the indicator lights illuminating.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (X-ray system) where a fault could lead to unintended radiation exposure, but no injuries or illnesses have been reported in the source text.
Plain-English summary
American Science & Engineering, Inc. is recalling 125 Gemini Cabinet X-ray systems. The recall was initiated after the manufacturer discovered during factory testing that the systems could experience a fault in rare circumstances. This fault leads to a state where 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.
The affected systems were distributed worldwide. In the United States, distribution included the states of NY, FL, TN, PA, NJ, DE, ME, TX, CT, MS, NC, MD, MO, VA, DC, NV, and GA. International distribution included Saudi Arabia, Indonesia, Canada, the Netherlands, Hong Kong, Lebanon, and Kazakhstan.
The source text does not specify specific actions for consumers or operators beyond the recall notice itself. Users of these systems should contact the manufacturer for further instructions regarding the identified fault.
The recalled product
- Product
- American Science & Engineering Inc,Gemini Cabinet X-ray system.
- Manufacturer
- American Science & Engineering, Inc.
- Affected units
- 125
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Gemini systems
Distribution
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