Olympus Scientific Solutions Americas Corporation (OSSA) Model: Analytical X-Ray System X -Ray Fluorescence. Intended to emit ionizing radiation Delta with models: DC-2000, DC-4000, DC-6000, DI-2000, DP-2000, DP-4000, DP-4050, DP- 6000, DPO-4000, DPO-6000, DS-2000, DS-4000, DS-6000, DS-6500, Delta, Delta 50, Delta Classic Plus, Delta Element, Delta Premium , Delta Professional , and Delta-Pl us.
FDA Recall Z-2255-2016 · Posted None
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Recalling FirmOlympus Scientific Solutions Americas
Recall StatusOpen, Classified
Product CodeRBY
Date Initiated2016-06-22
Product Quantity2, 210 units distributed in the USA
Reason for Recall
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.
Firm Action
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 [email protected], phone: +1 866 446 6689, fax: +1 781 419 3980, with questions or if additional information is needed.
Root Cause
Radiation Control for Health and Safety Act
Distribution Pattern
Nationwide Distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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