FDAClass IIAugust 10, 2016

Olympus Scientific Solutions Americas Corporation recall: Software Issue

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

Why was Olympus Scientific Solutions Americas Corporation 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All Models of the Delta XRF Analyzer with Software version 2.5.17.1 and higher

Product
Olympus Scientific Solutions Americas Corporation (OSSA) Model: Analytical X-Ray System X -Ray Fluorescence. Intended to emit ionizing radiation…
Recalling firm
Olympus Scientific Solutions Americas
Quantity
2, 210 units distributed in the USA
Distribution
Nationwide Distribution.
Recall date
August 10, 2016
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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