The Recall Desk
HighFDA (Devices)·Z-2991-2018·Announced 2018-09-26

Mobius AIRO Mobile CT System Recalled for Software Fault

Mobius Imaging is recalling 147 AIRO Mobile CT Systems because a software fault prevents the tube current modulation feature from working.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a functional defect in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Mobius Imaging, LLC is recalling 147 units of the AIRO Mobile CT System, Model # MobiCT-32. The recall involves systems equipped with software version 2.0.0.0. These devices were distributed in the United States and foreign markets.

The recall is due to a software defect where the Tube Current Modulation feature (Modulated Scans) is not functioning. Operators are unable to detect this fault until after a scan has been completed. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.

Consumers and healthcare facilities should contact Mobius Imaging, LLC for instructions on how to resolve the software issue. The recall number is Z-2991-2018.

The recalled product

Product
AIRO Mobile CT System Model # MobiCT-32
Manufacturer
Mobius Imaging, LLC
Category
Medical Device — Imaging Equipment
Hazard
Affected units
147

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Model # MobiCT-32

Distribution

Distribution scope not specified by the agency.

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