Device Recall Analytical XRay Fluorescence Systems of model family Delta 의 리콜

Recall

74593

Class 2

Z-2255-2016

2016-06-22

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148001

Trigger lock option does not always prevent x-ray generation. specifically if the unit is in test mode or repeat test mode then the trigger lock may not prevent x-ray initiation when the trigger is pulled. the correction is via repair by a software update.

The firm notified customers via an "Important - Electronic Product Radiation Warning" letter. It described the issue; and, told customers to not rely on the Trigger Lock feature until the software upgrade had been completed. The letter also provided instructions for customers to not only determine their software version; but, also instructions to bring their affected device into compliance. The firm will remedy the issue without charge. Customers can contact their local representative or OSSA at ani.technicalsupport@olympus-ossa.com, phone: +1 866 446 6689, fax: +1 781 419 3980, with questions or if additional information is needed.