FDA Medical Device Recalls (openFDA)
Mobius Imaging, LLC: AIRO Mobile CT System Model # MobiCT-32
- Recall number
- Z-2991-2018
- Recalling firm
- Mobius Imaging, LLC
- Product
- AIRO Mobile CT System Model # MobiCT-32
- Status
- Terminated
- Initiated
- 2018-08-01
- Posted
- not on file
- Terminated
- 2019-12-13
- 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.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- Mobius Imaging, LLC sent an URGENT MEDICAL DEVICE RECALL letter to customers advising that a voluntary recall related to the AIRO Mobile CT System was initiated. The letter included the reason for the recall and actions to be taken by the customers.
- Quantity
- 147
- Distribution
- US and foreign distribution.
- Lot, serial or model codes
- Model # MobiCT-32
- 510(k) numbers
- ["K180393"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 3010151377
- Firm city
- Shirley
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28