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Recall Observatory FDA recall evidence

Device product

Olympus Scientific Solutions Americas Corporation (OSSA) VANTA¿ XRF Analyzer. Model Vanta VCR and Vanta VMR Analytical X-ray systems

Z-1036-2017

January 07, 2017

Class II

Product summary

Firm
Olympus Scientific Solutions Americas
Event
Event 76208
Status
Terminated
Classification
Class II
Quantity
US 74
Official record key
device-enforcement:Z-1036-2017

Official wording

Reason: It was discovered under rare circumstances the LED warning light circuit could fail. If this happens, while the instrument is emitting X-rays during at test, the LED warning lights will not illuminate. The test runs normally and will execute as before, but the light will not be on.

Code information: affects all units.

Distribution pattern: US Distribution to the states of : PA, MA, CO, OH, NJ, GA, CA, TX, IL, VA, MN, NH, WA, SC, AZ, LA, MD, OK, IN, NY, NC and KS.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    It was discovered under rare circumstances the LED warning light circuit could fail. If this happens, while the instrument is emitting X-rays during at test, the LED warning lights will not illuminate. The test runs normally and will execute as before, but the light will not be on.

Field note

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