FDAFDA · Food and drugs·Recall number Z-2255-2016
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.
Published August 10, 2016 · Recall initiated: June 22, 2016
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
FDA Mandated · Letter
Recall details
- Manufacturer
- Olympus Scientific Solutions Americas
- Distributor
- Nationwide Distribution.
- Lot
- All Models of the Delta XRF Analyzer with Software version 2.5.17.1 and higher
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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