Mobius Imaging Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography recall — FDA Z-1040-2026
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
Overview of recall records associated with Mobius Imaging, LLC, including dates, categories and classifications where available.
Classification mix: Class II: 6.
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
Stryker received one report of an injury to an untrained user that occurred while the untrained user was moving an Airo TruCT unit in reverse. The firm will increase visibility of…
Stryker received a report of a battery fire involving an Airo TruCT unit previously subjected to bypass charging. The firm is notifying customers with units whose battery monitoring systems…
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…
If the tilt-drive motor has an intermittent connection or broken encoder or sensor wire there is a risk of unintended or unpredictable device motion while the CT system is homing the axis…
This page summarizes recall records in which the official source identifies Mobius Imaging, LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.