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Recall Observatory FDA recall evidence

Device product

Owandy Radiology I -MAX Touch 3D X-ray

Z-0129-2016

August 05, 2015

Class II

Product summary

Firm
Villa Radiology Systems LLC
Event
Event 71958
Status
Terminated
Classification
Class II
Quantity
I-MAX Touch 3D- 6 installed
Official record key
device-enforcement:Z-0129-2016

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 9306251191 and 9306651191

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).