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Recall Observatory FDA recall evidence

Device product

AIRO Mobile CT System Model # MobiCT-32

Z-2991-2018

August 01, 2018

Class II

Product summary

Firm
Mobius Imaging, LLC
Event
Event 80867
Status
Terminated
Classification
Class II
Quantity
147
Official record key
device-enforcement:Z-2991-2018

Official wording

Reason: The Tube Current Modulation feature (Modulated Scans) is not working in AIRO systems with software version 2.0.0.0, and operators would not be able to detect this fault until after a scan is completed.

Code information: Model # MobiCT-32

Distribution pattern: US and foreign distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The Tube Current Modulation feature (Modulated Scans) is not working in AIRO systems with software version 2.0.0.0, and operators would not be able to detect this fault until after a scan is completed.