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Recall Observatory FDA recall evidence

Device product

Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA Analytical X-Ray System

Z-0680-2017

October 27, 2016

Class II

Product summary

Firm
Olympus Scientific Solutions Americas
Event
Event 75575
Status
Terminated
Classification
Class II
Quantity
41 units
Official record key
device-enforcement:Z-0680-2017

Official wording

Reason: Possible unintentional x-ray emission after users attempt early termination of the sequence.

Code information: Model - Vanta VCR

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Possible unintentional x-ray emission after users attempt early termination of the sequence.