Device product
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.
Z-2255-2016
Product summary
- Event
- Event 74593
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2, 210 units distributed in the USA
- Official record key
device-enforcement:Z-2255-2016
Official wording
Reason: 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.
Code information: All Models of the Delta XRF Analyzer with Software version 2.5.17.1 and higher
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
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.