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Recall Observatory FDA recall evidence

Device product

Villa Sistemi Rotograph EVO 3D X-ray

Z-0128-2016

August 05, 2015

Class II

Product summary

Firm
Villa Radiology Systems LLC
Event
Event 71958
Status
Terminated
Classification
Class II
Quantity
Rotograph EVO 3D - 8 installed
Official record key
device-enforcement:Z-0128-2016

Official wording

Reason: It has been discovered that due to lack of information accompanying documents the product fails to comply with 21CfR 1020.33(c),1020.33(d),1020.33(g),and 1020.330).

Code information: p/n 9307251291, 9307351291, 9307651291

Distribution pattern: US Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    It has been discovered that due to lack of information accompanying documents the product fails to comply with 21CfR 1020.33(c),1020.33(d),1020.33(g),and 1020.330).