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U.S. Department of Health and Human Services

Class 2 Device Recall American Science & Engineering Inc, Gemini Cabinet Xray system

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  Class 2 Device Recall American Science & Engineering Inc, Gemini Cabinet Xray system see related information
Date Initiated by Firm May 22, 2015
Date Posted August 14, 2015
Recall Status1 Terminated 3 on February 22, 2017
Recall Number Z-2206-2015
Recall Event ID 71696
Product Classification Cabinet x-ray, security (includes baggage x-ray) - Product Code RCG
Product American Science & Engineering Inc,Gemini Cabinet X-ray system.
Code Information Gemini systems
Recalling Firm/
Manufacturer		 American Science & Engineering, Inc.
829 Middlesex Tpke
Billerica MA 01821-3907
For Additional Information Contact
978-262-8700
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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