Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

AIRO Mobile CT System Model # MobiCT-32

FDA Recall Z-2991-2018 · Posted None

Recalling FirmMobius Imaging, LLC
Recall StatusTerminated
Product CodeJAK
Date Initiated2018-08-01
Date Terminated2019-12-13
Product Quantity147

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.

Firm 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.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

US and foreign distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K180393AIRO Computed Tomography (CT) X-ray SystemMobius Imaging, LLC · 2018-03-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑