Reported Aug 10, 2016 · Ongoing

Olympus Scientific Solutions Americas Corporation (OSSA) Model: Analytical X-Ray System X -Ray Fluorescence. Intended…

Olympus Scientific Solutions Americas

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Olympus Scientific Solutions Americas · 48 Woerd Ave · Waltham, MA · 02453-3824

Is this the product you have?

  • Olympus Scientific Solutions Americas Corporation (OSSA)
  • ModelAnalytical 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
Lot codes and dates
  • All Models of the Delta XRF Analyzer with Software version 2.5.17.1 and higher
Amount recalled
2, 210 units distributed in the USA

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:59 PM UTC

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