AIRO Mobile CT System recall: Software Issue
AIRO Mobile CT System Model # MobiCT-32
Why was AIRO Mobile CT System recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model # MobiCT-32
- Product
- AIRO Mobile CT System Model # MobiCT-32
- Recalling firm
- Mobius Imaging, LLC
- Quantity
- 147
- Distribution
- US and foreign distribution.
- Recall date
- September 26, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)