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Recall Observatory FDA recall evidence

Device product

sterEOS workstation

Z-3188-2018

August 01, 2018

Class II

Product summary

Firm
EOS Imaging
Event
Event 80938
Status
Terminated
Classification
Class II
Quantity
17 units
Official record key
device-enforcement:Z-3188-2018

Official wording

Reason: 3D projections may be incorrect when the pair of images used is a secondary capture generated from a series containing more than two images, where one of the images has been manually flipped. Projection errors may lead to errors in calculation of 3D clinical parameters when adjusting the position, size and shape of the 3D objects used. Incorrect clinical parameters can be a contributing factor in incorrect clinical decisions, or sub-optimal surgical interventions.

Code information: All software versions are impacted

Distribution pattern: US nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    3D projections may be incorrect when the pair of images used is a secondary capture generated from a series containing more than two images, where one of the images has been manually flipped. Projection errors may lead to errors in calculation of 3D clinical parameters when adjusting the position, size and shape of the 3D objects used. Incorrect clinical parameters can be a contributing factor in incorrect clinical decisions, or sub-optimal surgical interventions.