Recall Z-2206-2015— American Science & Engineering, Inc.
Class II · Terminated
Class II FDA medical device recall by American Science & Engineering, Inc., initiated 2015-05-22, terminated 2017-02-22. FDA's recall record names no specific 510(k) clearance for this event. Product: American Science & Engineering Inc,Gemini Cabinet X-ray system.. 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..
- Recalling firm
- American Science & Engineering, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-05-22
- Terminated
- 2017-02-22
- Firm location
- Billerica, MA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.