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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- 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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