Z-2991-2018 Class II Terminated
FDA device recall Z-2991-2018 was initiated by Mobius Imaging, LLC on August 1, 2018 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated December 13, 2019). Affected quantity: 147.
Recall Details
- Product Type
- Devices
- Report Date
- September 26, 2018
- Initiation Date
- August 1, 2018
- Termination Date
- December 13, 2019
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 147
Product Description
AIRO Mobile CT System Model # MobiCT-32
Reason for Recall
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.
Distribution Pattern
US and foreign distribution.
Code Information
Model # MobiCT-32